Pharm D & Pharma D PB PDF

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PHARM. D. AND PHARM. D. (POST BACCALAUREATE)
REGULATIONS
These regulations shall be called as “The Regulations for the Pharm.D and Pharm.D.
(Post Baccalaureate) Degree courses of the JSS Academy of Higher Education &
Research, Mysore”. They shall come into force from the Academic Year 2008 –
2009. The regulations and syllabi framed are subject to modifications from time to
time by the Academic Council.
Minimum Qualification for admission to the course

1. Pharm.D.
A pass in any of the following examinations -
a. 10+2 examination with Physics and Chemistry as compulsorysubjects
along with one of the two subjects: Mathematics orBiology.
b. A pass in D.Pharm course from an institution approved by the Pharmacy
Council of India under section 12 of the PharmacyAct.
c. Any other qualification approved by the Pharmacy Council of India as
equivalent to any of the aboveexaminations.
d. Provided that a student should complete the age of 17 years on or before
31stDecember of the year of admission to thecourse.
e. Provided that there shall be reservation of seats for the students belonging
to the Scheduled Castes, Scheduled Tribes and other Backward Classes in
accordance with the instructions issued by the Central Government/State
Government/Union Territory Administration as the case may be from time
totime.
2. Pharm.D. (Post Baccalaureate)

A pass in B.Pharm from an institution approved by the Pharmacy Council of India
under section 12 of the Pharmacy Act:
Provided that there shall be reservation of seats for the students belonging to the
Scheduled Castes, Scheduled Tribes and other Backward Classes in accordance
with the instructions issued by the Central Government/State Government/Union
Territory Administration as the case may be from time to time.
Duration of the course

a. Pharm.D: The duration of the course shall be six academic years (five
years of study and one year of internship or residency). The period of six
years duration is divided into two phases–
PhaseI – consisting of First, Second, Third, Fourth and Fifth academicyear.
Phase II – consisting of internship or residency training during sixth year
involving posting in specialty units. It is a phase of training wherein a stu-
dent is exposed to actual pharmacy practice or clinical pharmacy services
and acquires skill under supervision of a preceptor so that he or she may
become capable of functioning independently.
b. Pharm. D. (Post Baccalaureate): The duration of the course shall be
for three academic years (two years of study and one year internship or
residency). The period of three years duration is divided into two phases–
Phase I – consisting of First and Second academic year.
Phase II – consisting of Internship or residency training during third year involv-
ing posting in specialty units. It is a phase of training wherein a student is exposed
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to actual pharmacy practice or clinical pharmacy services, and acquires skill under
supervision of a preceptor so that he or she may become capable of functioningin-
dependently.
Medium of Instruction and Examinations

Medium of Instruction and Examination shall be English.
Working days in the academic year

Each academic year shall consist of not less than 200 working days.
Attendance and Progress

A candidate is required to put in at least 80% attendance in theory and practical
subjects separately. The candidate shall complete the prescribed course satisfac-
torily to be eligible to appear for the respective examinations.
Course of study
The course of study for Pharm.D. shall include the subjects as given in the Tables
1 to 5. The number of hours in a week, devoted to each subject for its teaching in
theory, practical and tutorial shall not be less than that noted against it in columns
(3), (4) and (5) below.
Table-1 First Year

No. of No. of No. of
S.No. Name of Subject hours of hours of hours of
Theory Practical Tutorial
(1) (2) (3) (4) (5)
1.1 Human Anatomy and Physiology 3 3 1
1.2 Pharmaceutics 2 3 1
1.3 Medicinal Biochemistry 3 3 1
1.4 Pharmaceutical Organic Chemistry 3 3 1
Pharmaceutical Inorganic Chem-
1.5 2 3 1
istry
1.6 Remedial Mathematics/ Biology 3 3* 1
Total hours 16 18 6 = (40)
* For Biology
Table-2 Second Year

S.No Name of Subject hoursof hoursof hoursof
(1) (2) (3) (4) (5)
2.1 Pathophysiology 3 - 1
4
2.2 Pharmaceutical Microbiology 3 3 1
Pharmacognosy & Phytopharma-
2.3 3 3 1
ceuticals
2.4 Pharmacology-I 3 - 1
2.5 Community Pharmacy 2 - 1
2.6 Pharmacotherapeutics-I 3 3 1
Total Hours 17 9 6 = 32
Table-3 Third Year

S.No. Name of Subject No. of No. of No. of
hoursof hoursof hoursof
(1) (2) (3) (4) (5)
3.1 Pharmacology-II 3 3 1
3.2 Pharmaceutical Analysis 3 3 1
3.3 Pharmacotherapeutics-II 3 3 1
3.4 Pharmaceutical Jurisprudence 2 - -
3.5 Medicinal Chemistry 3 3 1
3.6 Pharmaceutical Formulations 2 3 1
Total hours 16 15 5 = 36
Table-4 Fourth Year

No. of
hours of
No. of No. of
Practi-
S.No. Name of Subject hours of hours of
cal/
Theory Tutorial
Hospital
Posting
(1) (2) (3) (4) (5)
4.1 Pharmacotherapeutics-III 3 3 1
4.2 Hospital Pharmacy 2 3 1
4.3 Clinical Pharmacy 3 3 1
Biostatistics & Research Methodol-
4.4 2 - 1
ogy
Biopharmaceutics & Pharmacoki-
4.5 3 3 1
netics
4.6 Clinical Toxicology 2 - 1
4.7 Pharmacotherapeutics I & II* 3 3 1

* Additional subject for Pharm.D (Post Baccalaureate) students
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Table-5 Fifth Year
No. of
No. of No. of
hours of
Sl.No. Name of Subject hours of hours of
Hospital
Theory Seminar
posting*
(1) (2) (3) (4) (5)
5.1 Clinical Research 3 - 1
Pharmacoepidemiology and
5.2 3 - 1
Pharmacoeconomics
Clinical Pharmacokinetics &
5.3 Pharmacotherapeutic Drug Moni- 2 - 1
toring
5.4 Clerkship * - - 1
5.5 Project work (Six Months) - 20 -
* Attending ward rounds on daily basis.
Sixth Year:
Internship or residency training including postings in speciality units. Student
should provide the clinical pharmacy services to the allotted wards, under the su-
pervision of a preceptor.
1. Six months in General Medicine department,and
2. Two months each in three other specialtydepartments
Academic Work
A regular record of attendance both in Theory and Practical shall be maintained by
the teaching staff of respective subjects.
Internal Assessment Marks:

Theory: Three sessional examinations evenly spread during the academic year
shall be conducted by the constituent colleges. The average marks of the best two
examinations shall be computed out of a maximum of 30 marks and shall consti-
tute the sessional award in theory. Provided further the colleges may conduct one
special theory sessional examination towards the end of the academic session for
those who might have missed any one of the regular sessional examination on
genuinegrounds.
Practical: Students are expected to perform the experiment listed in the respective
syllabus. Marks shall be awarded out of a maximum of 10 to each of the practical
exercise and an average of those shall be computed out of maximum of 10 marks.
In addit ion, three practical examinations evenly spread during each academic year
shall be conducted. The average marks of the best of two practical examinations
shall be computed out of a maximum of 20 marks. A total of 30 marks shall con-
stitute the sessional award in practical. While awarding the sessional marks for
practical experiments, the following considerations should be taken intoaccount.
1. Preparation of thecandidate.
2. Manipulative skills.
3. Results of theexperiment.
4. Knowledge of theexperiment
5. Viva voce pertaining to the experimentsonly.
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The college shall maintain the sessional books of the students and the record of
sessional award of the students. A regular record of both theory and practical class
work and sessional examinations conducted in an institution imparting the course
shall be maintained for each student in the institution. Marks shall be awarded as
per the schemes given in Tables 6 to 10
Conditions under which candidates are permitted to appear for Deemed

to be University examination The candidates are required to score a minimum
of 50% marks in each of the subjects (Theory and practicals separately) in the
sessional examination to be eligible to appear for Deemed to be University exam-
ination in the respective subject.
Deemed to be University Examinations

1. Every year there shall be an examination to examine thestudents.
2. Each examination will be held twice every year. The first examination in a
year shall be the annual examination and the second examination shall be
supplementaryexamination.
3. The examinations shall be of written and practical (including oral nature)
carrying maximum marks for each part of a subject as indicated in Tables
6to10.
Table-6 First Year Examination
Sl. Name of Maximum marks for Prac-
Maximum marks for Theory
No. Subject ticals
Deemed Deemed
to be Ses- to be Ses-
Total Total
Univer- sional Univer- sional
sity sity
Human
Anatomy
1.1 70 30 100 70 30 100
and
Physiology
Pharma-
1.2 70 30 100 70 30 100
ceutics
Medicinal
1.3 Biochem- 70 30 100 70 30 100
istry
Pharma-
ceutical
1.4 70 30 100 70 30 100
Organic
Chemistry
Pharma-
ceutical
1.5 70 30 100 70 30 100
Inorganic
Chemistry
Remedial
Mathemat-
1.6 70 30 100 70* 30* 100*
ics/
Biology
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1000/
500 /600 1100/
1200
* For Biology.
For PCMB students: 1000 marks, For PCB students: 1100 marks, For PCM stu-
dents: 1200 marks
Table-7 Second Year Examination
Sl. Name of Maximum marks for The- Maximum marks for Prac-
No. Subject ory ticals
Deemed
Deemed
Ses- to be Ses-
to be Uni- Total Total
sional Univer- sional
versity
sity
Pathophysi-
2.1 70 30 100 - - -
ology
Pharma-
ceutical
2.2 70 30 100 70 30 100
Microbiol-
ogy
Pharma-
cognosy &
2.3 70 30 100 70 30 100
Phytophar-
maceuticals
Pharmacol-
2.4 70 30 100 - - -
ogy-I
Community
2.5 70 30 100 - - -
Pharmacy
Pharmaco-
2.6 therapeu- 70 30 100 70 30 100
tics-I
300 =
600
900
Table-8 Third Year Examination
Deemed
Deemed
Ses- to be Ses-
to be Uni- Total Total
sional Univer- sional
versity
sity
Pharmacol-
3.1 70 30 100 70 30 100
ogy-II
Pharmaceu-
3.2 tical Anal- 70 30 100 70 30 100
ysis
Pharmaco-
3.3 therapeu- 70 30 100 70 30 100
tics-II
8
Pharmaceu-
tical
3.4 70 30 100 - - -
Jurispru-
dence
Medicinal
3.5 70 30 100 70 30 100
Chemistry
Pharmaceu-
3.6 tical Formu- 70 30 100 70 30 100
lations
500 =
600
1100
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Table-9 Fourth Year Examination
Deemed Deemed
Total Total
sity sity
Pharmaco-
4.1 therapeu- 70 30 100 70 30 100
tics-III
Hospital
4.2 70 30 100 70 30 100
Pharmacy
Clinical Phar-
4.3 70 30 100 70 30 100
macy
Biostatistics
4.4 & Research 70 30 100 - - -
Methodology
Biopharma-
ceutics &
4.5 70 30 100 70 30 100
Pharmacoki-
netics
Clinical Toxi-
4.6 70 30 100 - - -
cology
400 =
600
1000
Pharmaco-
4.7 therapeutics 70 30 100 70 30 100
I & II*
500 =
700
1200
Table-10 Fifth Year Examination

Sl. Name of Maximum marks for The- Maximum marks for
No. Subject ory Practicals
Deemed Deemed
Total Total
sity sity
Clinical Re-
5.1 70 30 100 - - -
search
Pharmacoep-
idemiology
5.2 and 70 30 100 - - -
Pharma-
coeconomics
10
Clinical Phar-
macokinetics
& Pharmaco-
5.3 70 30 100 - - -
therapeutic
Drug Moni-
toring
5.4 Clerkship * - - - 70 30 100
Project work
5.5 - - - 100** - 100
(Six Months)
200 =
300
500
* Clerkship examination – Oral examination shall be conducted after the comple-

tion of clerkship of students. An external and an internal examiner will evaluate
the student. Students may be asked to present the allotted medical cases followed
by discussion. Students’ capabilities in delivering clinical pharmacy services, phar-
maceutical care planning and knowledge of therapeutics shall beassessed.
** 30 marks – viva-voce (oral), 70 marks – Thesis work
Question Pattern
Long Essay2/3 = 2 x 15 = 30marks
ShortEssay6/8 = 6 x 5 = 30marks
ShortAnswers5/7 = 5 x 2 = 10marks
.................................
Total
70marks
.................................
Criteria for pass

a. Candidates who have secured a minimum of 50% marks in the Theory
(including sessionals) and Practical (including sessionals) separately in any
subject or subjects shall be declared to have passed in that subject/s and
exempted from appearing in that subject/s at subsequentexamination.
b. Theory and Practical of a particular subject are considered as individual
subjects for the purpose of passcriteria.
c. Those candidates who fail in one or more subjects shall have to appear
only in the subject so failed, in the subsequentexaminations.
Conditions under which candidates are permitted to proceed to next high-

er class:
a. Pharm.D
1. Candidates of I Pharm.D are permitted to carry not more than any two
subjects (Two Theory/ Two Practicals/ One theory & one practical of same
or different subjects) to II Pharm.D and appear for II Pharm.D examina-
tion concurrently along with failed subjects of I Pharm.D. However, these
candidates have to pass all the failed subjects of I Pharm.D to become
eligible to IIIPharm.D.
2. Similarly, candidates of II Pharm.D who have completely passed all the
subjects of I Pharm.D but have failed in II Pharm.D are permitted to carry
not more than any two subjects (Two Theory/ Two Practicals/ One theory
& one practical of same or different subjects) of II Pharm.D to III Pharm.D
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and appear for III Pharm.D concurrently along with failed subjects of II
Pharm.D. However, these candidates have to pass all the failed subjects of
II Pharm.D to become eligible to proceed to IV Pharm.D.
3. Candidates of III Pharm.D who have completely passed all the subjects of
II Pharm.D but have failed in III Pharm.D are permitted to carry not more
than any two subjects (Two Theory/ Two Practicals/ One theory & one
practical of same or different subjects) of III Pharm.D to IV Pharm.D and
appear for IV Pharm.D examination concurrently along with failed subjects
of III Pharm.D. However, these candidates have to pass all the failed sub-
jects of III Pharm.D to become eligible to proceed to V Pharm.D.
4. Candidates of IV Pharm.D who have completely passed all the subjects of
III Pharm.D but have failed in IV Pharm.D are permitted to carry not more
than any two subjects (Two Theory/ Two Practicals/ One theory & one
practical of same or different subjects) of IV Pharm.D to V Pharm.D and
appear for V Pharm.D examination concurrently along with failed subjects
of IV Pharm.D. However, these candidates have to pass all the failed sub-
jects of IV and V Pharm. D to become eligible to proceed to VI Pharm. D.,
to undergointernship.
b. Pharm.D. (PostBaccalaureate)
Candidates of Pharm. D. (Post Baccalaureate) admitted directly to IV year course
are permitted to carry not more than any two subjects (Two Theory/ Two Prac-
ticals/ One theory & one practical of same or different subjects) to V Pharm.D.
and appear for V Pharm. D. examination concurrently along with failed subjects
of IV Pharm. D. However, these candidates have to pass all the subjects of IV &
V Pharm. D to become eligible to proceed to VI Pharm. D., to undergointernship.
Declaration of class
a. Pharm.D
Class shall be awarded at the end of I, II, III, IV and V year of Pharm.D. examina-
tion as shown below:
1. Distinction 75% andabove
2. FirstClass 60% and above and less than75%
3. Secondclass 50% and above and less than60%
The result of the successful candidate shall be classified at the end of the final year
examination on the basis of the aggregate of all subjects, theory and practicals,
secured by the candidate in the I to V year examinations and completes the course
in 5 years, as indicated below.
1. Class : 60% andabove
2. Class :50%-59%
Candidate securing aggregate of 75% or above marks and have passed in all the
subjects in a year in first attempt shall be declared to have obtained Distinction.
Internship
Internship is a phase of training wherein a student is expected to conduct actual
practice of pharmacy and healthcare and acquires skills under the supervision so
that he or she may become capable of functioning independently. Every student
has to undergo one year internship as per Pharmacy Council of India regulations.
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Practical training
1. Hospital posting.― Every student shall be posted in constituent hospital
for a period of not less than fifty hours to be covered in not less than 200
working days in each of second, third & fourth year course of Pharm.D
and in first and second year of Pharm.D. (Post Baccalaureate). Each stu-
dent shall submit report duly certified by the preceptor and duly attested
by the Head of the Department or Institution as prescribed. In the fifth
year, every student shall spend half a day in the morning hours attending
ward rounds on daily basis as a part of clerkship. Theory teaching may be
scheduled in theafternoon.
2. Project work.― (1) To allow the student to develop data collection and
reporting skills in the area of community, hospital and clinical pharmacy,
a project work shall be carried out under the supervision of a teacher. The
project topic must be approved by the Head of the Department or Head
of the Institution. The same shall be announced to students within one
month of commencement of the fifth year classes of Pharm.D and second
year of Pharm.D. (Post Baccalaureate). Project work shall be presented in
a written report and as a seminar at the end of the year. External and the
internal examiners shall do the assessment of the projectwork. (2) Project
work shall comprise of objectives of the work, methodology, results, dis-
cussions and conclusions.
3. Objectives of project work.― The main objectives of the project work
isto―
• show the evidence of having made accurate description of published
work of others and of having recorded the findings in an impartial
manner; and
• develop the students in data collection, analysis and reporting and
interpretationskills.
4. Methodology.― To complete the project work following methodology shall

be adopted, namely:―
• students shall work in groups of not less than two and not more than
four under an authorisedteacher;
• project topic shall be approved by the Head of the Department or
Head of the Institution;
• project work chosen shall be related to the pharmacy practice in com-
munity, hospital and clinical setup. It shall be patient and treatment
(Medicine) oriented, like drug utilisation reviews, pharmacoepidemiol-
ogy, pharmacovigilance or pharmacoeconomics;
• project work shall be approved by the institutional ethicscommittee;
• student shall present at least three seminars, one in the beginning,
one at middle and one at the end of the project work;and
• two-page write-up of the project indicating title, objectives, method-
ology anticipated benefits and references shall be submitted to the
Head of the Department or Head of the Institution.
5. Reporting .―
• (1) Student working on the project shall submit jointly to the Head of
the Department or Head of the Institution a project report of about
40-50 pages. Project report should include a certificate issued by the
authorised teacher, Head of the Department as well as by the Head of
theInstitution
• Project report shall be computer typed in double space using Times
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Roman font on A4 paper. The title shall be in bold with font size 18,
sub-tiles in bold with font size 14 and the text with font size 12. The
cover page of the project report shall contain details about the name
of the student and the name of the authorised teacher with font size
14.
• Submission of the project report shall be done at least one month pri-
or to the commencement of annual or supplementaryexamination.
6. Evaluation.― The following methodology shall be adopted for evaluating
the project work―
• Project work shall be evaluated by internal and externalexaminers.
• Students shall be evaluated in groups for four hours (i.e., about half an
hour for a group of fourstudents).
• Three seminars presented by students shall be evaluated for twenty marks
each and the average of best two shall be forwarded to the Deemed to be
University with marks of other subjects.
• Evaluation shall be done on thefollowingitems: Marks
a. Write up oftheseminar (7.5)
b. Presentationofwork (7.5)
c. Communicationskills (7.5)
d. Question andanswerskills (7.5)
Total (30marks)
• Final evaluation of project work shall be done on the following items:

Marks
a. Write up oftheseminar (17.5)
b. Presentationofwork (17.5)
c. Communicationskills (17.5)
d. Question andanswerskills (17.5)
Total (70marks)
Explanation.― For the purposes of differentiation in the evaluation in case of topic

being the same for the group of students, the same shall be done based on item
numbers b, c and d mentionedabove.
Award ofRanks
Ranks and Medals shall be awarded on the basis of aggregate of all the five and
two Deemed to be University examinations of Pharm.D. and Pharm.D. (Post Bac-
calaureate), respectively. However, candidates who fail in one or more subjects
during the Pharm.D/ Pharm.D. (Post Baccalaureate) courses shall not be eligible
for award ofranks.
Moreover, the candidates should have completed the Pharm.D course in minimum
prescribed number of years, (five years for Pharm.D and two years for Pharm.D.
(Post Baccalaureate)) for the award of Ranks.
Award of degree
Candidates who fulfill the requirements mentioned above will be eligible for award
of degree during the ensuing convocation.
Duration for completion of the course of study
The duration for the completion of the course shall be fixed as double the actual
duration of the course and the students have to pass within the said period, other-
wise they have to get fresh Registration.
Revaluation I Retotalling of answer papers
There is no provision for revaluation of the answer papers of failed candidates in
any examination. However, the failed candidates can apply for retotalling.
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Re-admission after break of study
Candidate who seeks re-admission to the course after break of study has to get the
approval from the Deemed to be University by paying a condonation fee.
No condonation is allowed for the candidate who has more than 2 years of break
up period and he/she has to rejoin the course by paying the required fees.
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Syllabus
Pharm. D. - First Year
No. of
No. of
Sl. hoursof No. of hours
Name of Subject hoursof
No. Practi- of Tutorial
Theory
cal
(1) (2) (3) (4) (5)
1.1 Human Anatomy and Physiology 3 3 1
1.2 Pharmaceutics 2 3 1
1.3 Medicinal Biochemistry 3 3 1
1.4 Pharmaceutical Organic Chemistry 3 3 1
Pharmaceutical Inorganic Chem-
1.5 2 3 1
istry
1.6 Remedial Mathematics/ Biology 3 3* 1
5/6+*
Total hours 13/16+ 15/18* =
33/37+/40*
+ For Mathematics (PCB students)
* For Biology (PCM students)
1.1 HUMAN ANATOMY & PHYSIOLOGY (THEORY)
Theory: 3 Hrs. /Week
1. Scope and Objectives: This course is designed to impart a fundamental

knowledge on the structure and functions of the human body. It also helps
in understanding both homeostasis mechanisms and homeostatic imbal-
ances of various body systems. Since a medicament, which is produced by
pharmacist, is used to correct the deviations in human body, it enhances
the understanding of how the drugs act on the various body systems in
correcting the disease state of theorgans.
Upon completion of the course the student shall be able to:

a. describe the structure (gross and histology) and functions of various
organs of the humanbody;
b. describe the various homeostatic mechanisms and their imbalances of
various systems;
c. identify the various tissues and organs of the different systems of the
humanbody;
d. perform the hematological tests and also record blood pressure, heart
rate, pulse and respiratoryvolumes;
e. appreciate coordinated working pattern of different organs of each
system;and
f. appreciate the interlinked mechanisms in the maintenance of normal
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functioning (homeostasis) of humanbody
2. Course materials:
Text books
a. Gerard J. Tortora and Bryan Derrickson. Principles of anatomy and
physiology, Publisher Harpercollins College NewYork.
b. Anne Waught & Allison Grant. Ross and Wilson’s foundations of Anatomy and
Physiology in Health and Ilness. Publisher: Churchill Livingstone,Edinburg.
Reference books
a. Guyton arthur, C. Physiology of human body. Publisher:Holtsaunders.
b. Chatterjee, C.C. Human physiology. Volume 1&11. Publisher: medical
allied agency, Calcutta.
c. Peter L. Williams, Roger Warwick, Mary Dyson and Lawrence, H.
Gray’sanatomy.
d. Publisher: Churchill Livingstone, London.
e. K. Sembulingam & Prema Sembulingam, Medical Physiology, 4th Edition.
Publisher: Jaypee Brothers
3. Lecture wiseprogram:
Topics Hrs
Scope of anatomy and physiology, basic terminologies used in
1 this subject (Description of the body as such planes and termi- 01
nologies)
General Physiology: Structure of cell – its components and their
2 functions. Homeostasis, Mechanism of transport across cell mem- 04
brane, Secondary messengers, Ion channels
Elementary tissues of the human body: epithelial, connective,
3 04
muscular and nervous tissues-their sub-types and characteristics
a. Osseous system - structure, composition and functions
ofthe skeleton. (done in practical classes -6hrs)
4 01
b. Classification of joints, types of movements of joints and
disordersof joints (Definitionsonly)
Haemopoetic system
1. Composition and functions ofblood
2. Haemopoesis and disorders of blood components (Defini-
5 tiononly) 05
3. Bloodgroups
4. Clotting factors andmechanism
5. Platelets and disorders ofcoagulation
Lymph
a. Lymph and lymphatic system, composition, formation
6 andcirculation. 04
b. Spleen: structure and functions,disorders
c. Disorders of lymphatic system (Definitiononly)
17
Cardiovascular system
a. Anatomy and functions ofheart
b. Blood vessels and circulation (Pulmonary, coronary
andsystemic circulation)
c. Electrocardiogram(ECG)
7 d. Cardiac cycle and heartsounds 06
e. Blood pressure – its maintenance and regulation
f. Definition of the followingdisorders
g. Hypertension, hypotension, arteriosclerosis,
atherosclerosis, angina, myocardial infarction, congestive
heart failure, cardiac arrhythmias
Respiratory system
a. Anatomy of respiratory organs andfunctions
b. Mechanism / physiology of respiration and regulation
8 ofrespiration 05
c. Transport of respiratorygases
d. Respiratory volumes and capacities, and definition of:
hypoxia,asphyxia, oxygen therapy andresuscitation.
Digestive system
a. Anatomy and physiology ofGIT
9 b. Anatomy and functions of accessory glands ofGIT 06
c. Digestion andabsorption
d. Disorders of GIT (Definitionsonly)
Nervous system
a. Definition and classification of nervoussystem.
b. Synapse and neurotransmitter, meninges, ventricles of the
brain andCSF
c. Anatomy, physiology and functional areas ofcerebrum
d. Anatomy and physiology ofcerebellum
10 08
e. Anatomy and physiology of midbrain
f. Thalamus, hypothalamus and basalganglia
g. Spinal card: Structure & reflexes –mono-poly-planter
h. Cranial nerves – names andfunctions
i. ANS – Anatomy & functions of sympathetic & parasympa-
theticN.S.
Urinary system
a. Anatomy and physiology of urinarysystem
b. Formation ofurine
11 05
c. Renin angiotensin aldosterone system – Juxtaglomerular
apparatus - acid base balance
d. Clearance tests andmicturition
18
Endocrine system
a. Pituitarygland
12 b. Adrenalgland 06
c. Thyroid and Parathyroidglands
d. Pancreas and gonads
Reproductive system
a. Male and female reproductive system organs anatomy
andphysiology.
b. Their hormones – physiology ofmenstruation
13 07
c. Spermatogenesis &Oogenesis
d. Sex determination (geneticbasis)
e. Pregnancy & maintenance.Parturition
f. Contraceptive devices
Sense organs
a. Eye
14 b. Ear 06
c. Skin
d. Tongue &Nose
Skeletalmuscles
a. Histology
15 b. Physiology of Musclecontraction 03
c. Physiological properties of skeletal muscle and theirdisor-
ders (Definitions only)
Sports physiology
a. Muscles in exercise, Effect of athletic training on muscles
andmuscle performance,
16 03
b. Respiration in exercise, CVS in exercise, body heat in exer-
cise, body fluids and salts inexercise,
c. Drugs andathletics
1.1 HUMAN ANATOMY & PHYSIOLOGY(PRACTICAL)
Practical: 3 Hrs/Week
General Requirements: Laboratory napkin, muslin cloth, record, observation

book (100pages), stationary items, and blood lancet.
Course materials:
Text books
Goyal, R. K, Natvar M.P, and Shah S.A, Practical anatomy, physiology and bio-
chemistry, latest edition, Publisher: B.S Shah Prakashan, Ahmedabad.
Reference books
Ranade VG, Text book of practical physiology, Latest edition, Publisher: PVG, Pune
Anderson Experimental Physiology, Latest edition, Publisher: NA
List of Experiments:
1. Study of compoundmicroscope.
2. Study of tissues of humanbody
a. Epithelialtissue.
b. Musculartissue.
3. Study of tissues of humanbody
19
a. Connective tissue.
b. Nervoustissue.
4. Study of appliances used in haematologicalexperiments.
5. Determination of total WBC count ofblood.
6. Determination of total RBC count ofblood.
7. Determination of differential leukocyte count ofblood.
8. Determinationof
a. Erythrocyte Sedimentation Rate.(ESR)
b. Hemoglobin content ofblood.
c. Bleeding time & clottingtime.
9. Determinationof
a. Bloodpressure.
b. Bloodgroup.
10. Study of various systems with the help of charts, models &specimens
a. Skeleton system part I-axialskeleton.
b. Skeleton system part II- appendicularskeleton.
c. Cardiovascularsystem.
d. Respiratorysystem.
e. Digestive system.
f. Urinarysystem.
g. Nervoussystem.
h. Specialsenses.
i. Reproductive system.
11. Study of different family planningappliances.
12. Study of pregnancy diagnosistest.
13. Study of appliances used in experimentalphysiology.
14. Study of record of simple muscle curve using gastrocnemius sciatic nerve-
preparation.
15. Study of simple summation curve using gastrocnemius sciatic nerveprepa-
ration.
16. Study of simple effect of temperature using gastrocnemius sciatic nerve-
preparation.
17. Study of simple effect of load & after load using gastrocnemius sciatic
nerve preparation.
18. Study of fatigue curve using gastrocnemius sciatic nervepreparation.
Scheme of Practical Examination:

Sessionals Annual
Identification 04 10
Synopsis 04 10
Major Experiment 07 20
Minor Experiment 03 15
Viva 02 15
20
Max Marks 20 70
Duration 03hrs 04hrs
Note: Total sessional marks is 30 (20 for practical sessional plus 10 marks for reg-
ularity, promptness, viva-voce and record maintenance).
1.2 PHARMACEUTICS(THEORY)
Theory : 2 Hrs. /Week
1. Scope and objectives: This course is designed to impart a fundamental

knowledge on the art and science of formulating different dosage forms. It
prepares the students for most basics of the applied field ofpharmacy.
Upon the completion of the course the student should be able to:
• know the formulation aspects of different dosageforms;
• do different pharmaceutical calculation involved informulation;
• formulate different types of dosage forms;and
• appreciate the importance of good formulation foreffectiveness.
Text books
• Cooper and Gunns Dispensing for pharmacystudents.
• A text book Professional Pharmacy by N.K.Jain andS.N.Sharma.
Reference books
• Introduction to Pharmaceutical dosage forms by Howard C.Ansel.
• Remington’s PharmaceuticalSciences.
• Register of General Pharmacy by Cooper andGunn.
• General Pharmacy byM.L.Schroff.
3. Lecture wiseprogramme:
Topics Hrs
a. Introduction to dosage forms - classification anddefinitions
b. Prescription: definition, parts andhandling
1 06
c. Posology: Definition, Factors affecting dose selection. Calcula-
tion of children and infantdoses.
History of profession of Pharmacy in India in relation to pharmacy
2 03
education, industry and organization in brief.
Development of Indian Pharmacopoeia. Salient features of latest
edition of IP (IP 2008) and introduction to other Pharmacopoeias
3 03
such as BP, USP, European Pharmacopoeia, Extra pharmacopoeia and
Indian National formulary.
Weights and measures, Calculations involving percentage solutions,
4 06
allegation, proof spirit, isotonic solutions.
Powders and Granules: Classification advantages and disadvantag-
es, Preparation of simple, compound powders, Insufflations, Dusting
5 05
powders, Eutectic and Explosive powders, Tooth powder and effer-
vescent powders and granules.
21
Monophasic Dosage forms: Theoretical aspects of formulation includ-
ing adjuvant like Vehicles, Organoleptic additives and Stabilizers,
with examples. Study of Monophasic liquids (formulation aspects and
6 06
examples) like gargles, mouth washes,
Throat paint, Ear drops, Nasal drops, Liniments and lotions, Enemas
and collodions.
Biphasic dosage forms: Suspensions and emulsions, Definition, ad-
vantages and disadvantages, classification and formulation of Sus-
7 06
pensions and Emulsions. Test for the type of emulsion and stability
problems in emulsions.
Suppositories: Definition, advantages and disadvantages, types of
8 03
base, method of preparation, Displacement value and evaluation.
Galenicals: Definition, of different extraction processes like infusion,
9 Decoction, Maceration and Percolation. Study of Maceration and Per- 06
colation processes
Surgical aids: Surgical dressings, sutures, ligatures and preparation
10 04
of surgical catgut.
Incompatibilities: Introduction, classification, Examples and methods
11 02
to overcome Physical and therapeutic incompatibilities.
1.2 PHARMACEUTICS(PRACTICAL)
Practical : 3 Hrs./Week
1. Syrups
• Simple SyrupI.P
• Syrup of Ephedrine HydrochlorideNF
• Orange Syrup
2. Elixir
• Piperizine citrate elixirBP
• Paracetamol elixirBPC
3. Linctus
• Simple linctusBPC
• Pediatric simple linctusBPC
4. Solutions
• Solution of cresol with soapIP
• Aqueous Iodine SolutionIP
• Strong solution of IodineIP
• Strong solution of ammonium acetateIP
5. Liniments
• Liniment of turpentineIP*
• Liniment of camphorIP
6. Suspensions*
• Calaminelotion
• Magnesium Hydroxide mixtureBP
7. Emulsions*
• Cod liver oilemulsion
• Liquid paraffinemulsion
22
8. Powders
• Eutecticpowder
• Dustingpowder
• d.Insufflations
9. Suppositories
• Boric acidsuppositories
• Chloralsuppositories
10. Incompatibilities
• Preparations having with Physical Incompatibilities (3Nos)
* colourless bottles required for dispensing *Paper envelope (white), butter paper
and white paper required for dispensing.

Sessionals Annual
Synopsis 05 15
Major
10 25
Experiment
Minor
03 15
Experiment
Viva 02 15
Max Marks 20 70
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for
regularity, promptness, viva-voce and record maintenance).
1.3 MEDICINAL BIOCHEMISTRY(THEORY)

1. Scope and Objectives: Biochemistry deals with complete understanding of
the molecular level of the chemical process associated with living cells in normal
and abnormal state. Clinical chemistry deals with the study of chemical aspects
of human life in health and illness and the application of chemical laboratory
methods to diagnosis, control of treatment and prevention ofdiseases.
The objective of the present course is providing biochemical facts and the princi-
ples to the students ofpharmacy.
Upon completion of the course student shall be able to –

1. understand the catalytic activity of enzymes and importance of enzymes in
diagnosis of diseases and therapeuticagents;
2. know the metabolic pathways of biomolecules in health and illness (meta-
bolic disorders);
3. understand the genetic organization of mammalian genome, protein syn-
thesis, replication, mutation and repairmechanism.
4. know the biochemical principles of organ function tests of kidney, liver and
endocrine gland;and
5. do the qualitative analysis and determination of biomolecules in the body
fluids and their clinicalsignificance.
2. Course materials:Text books(Theory)
1. Harpers review of biochemistry -Martin
23
2. Text book of biochemistry –D.Satyanarayana
3. Text book of clinical chemistry- Alex Kaplan &LaverveL.Szabo
Reference books (Theory)

1. Principles of biochemistry -Lehninger
2. Text book of biochemistry -Ramarao
3. Practical Biochemistry-David T.Plummer.
4. PracticalBiochemistry-Pattabhiraman.
3. Lecture wise programme:

Topics Hrs
Introduction to biochemistry: Cell and its biochemical organiza-
1 tion, transport process across the cell membranes. Energy rich com- 05
pounds; ATP, Cyclic AMP and their biological significance.
Enzymes: Definition; Nomenclature; IUB classification; Factor af-
fecting enzyme activity; Enzyme action; enzyme inhibition. Isoen-
2 10
zymes and their therapeutic and diagnostic applications; Coenzymes
and their biochemical role and deficiency diseases.
Carbohydrate metabolism: Glycolysis, citric acid cycle (TCA cy-
cle), HMP shunt, Glycogenolysis, glycogenesis gluconeogenesis. Met-
abolic disorders of carbohydrate metabolism (diabetes mellitus and
3 11
glycogen storage diseases); Glucose tolerancetest
and its significance; hormonal regulation of carbohydrate metabo-
lism.
Lipid metabolism: β-Oxidation of saturated fatty acid; Ketogenesis

and ketolysis; biosynthesis of fatty acids and lipids; metabolism of
4 09
cholesterol; Hormonal regulation of lipid metabolism. Defective me-
tabolism of lipids (Atheroslerosis, fatty liver,hypercholesterolmiea).
Biological oxidation: Enzymes and Coenzyme system involved in
Biological oxidation. Electron transport chain (its mechanism in en-
5 04
ergy capture, regulation and inhibition); Oxidative phosphorylation
and uncouplers of ETC.
Protein and amino acid metabolism: protein turn over; nitrogen
balance; general reactions of catabolism of amino acids (Transami-
6 nation, deamination & decarboxylation). Urea cycle and its metabolic
disorders; production of bile pigments; hyperbilirubinemia, porpho-
rias, jaundice. Metabolic disorder of Amino acids. 08
Nucleic acid metabolism: Metabolism of purine and pyrimidine nu-
cleotides; Protein synthesis; Genetic code; inhibition of protein syn-
7
thesis; DNA damage and repair mechanism; DNA replication (semi
12
conservative).
24
The kidney function tests: Role of kidney; Laboratory tests for
normal function includes-
a. Urine analysis (macroscopic and physical examination, quanti-
tative and semi quantitative tests.)
8
b. Test for NPN constituents. (Creatinine /urea clearance, deter-
mination of blood/ urine creatinine, urea and uricacid)
c. Urine concentrationtest
03
d. Urinary tract calculi.(stones)
Liver function tests: Physiological role of liver, metabolic, storage,

excretory, protective, circulatory functions and function in blood co-
agulation.
a. Test for hepatic dysfunction-Bile pigmentsmetabolism.
9 b. Test for hepatic function test- Serum bilirubin, urine bilirubin,
and urine urobilinogen.
c. Dye tests of excretoryfunction.
d. Tests based upon abnormalities of serumproteins. 04
e. Selected enzyme activity determinationtests.
Lipid profile tests: Lipoproteins, composition, functions. Determi-

10 nation of serum lipids, total cholesterol, HDL cholesterol, LDL choles-
terol and triglycerides. 02
Immunochemical techniques for determination of hormone lev-
els and protein levels in serum for endocrine diseases and infectious
11
diseases. Radio immuno assay (RIA) and Enzyme Linked Immuno
03
Sorbent Assay (ELISA).
Electrolytes: Body water, compartments, water balance, and elec-
trolyte distrubution.
12
Determination of sodium, calcium potassium, chlorides, bicarbonates 03
in the body fluids.
1.3 MEDICINAL BIOCHEMISTRY(PRACTICAL)

Practical: 3 Hrs. /Week
Title of the Experiment:

1. Qualitative analysis of normal constituents ofurine.
2. Qualitative analysis of abnormal constituents ofurine.
3. Quantitative estimation of urine chlorides by Volhard’smethod.
4. Quantitative estimation of urine creatinine by Jaffe’smethod.
5. Quantitative estimation of urine calcium by precipitationmethod.
6. Quantitative estimation of serumcholesterol.
7. Preparation of Folin Wu filtrate fromblood.
8. Quantitative estimation of bloodcreatinine.
9. Quantitative estimation of blood sugar Folin-Wu tube method.
10. Estimation of SGOT inserum.
11. Estimation of SGPT in serum.
12. Estimation of Urea in Serum.
13. Estimation of Proteins in Serum.
14. Determination of serum bilirubin
15. Determination of Glucose by means of Glucoseoxidase.
25
16. Enzymatic hydrolysis of Glycogen/Starch by Amylases.
17. Study of factors affecting Enzyme activity. (pH &Temp.)
18. Preparation of standard buffer solutions and its pH measurements (any
two)
19. Experiment on lipid profile tests
20. Determination of sodium/calcium/potassium in serum.

Sessionals Annual
Synopsis 05 15
Viva 02 15
Max Marks 20 70
Note: Total sessional marks is 30(20 for practical sessional plus 10 marks for reg-
1.4 PHARMACEUTICAL ORGANIC CHEMISTRY(THEORY)

1. Scope and objectives: This course is designed to impart a very
good knowledgeabout
• IUPAC/Common systems of nomenclature of simple organic com-
pounds belonging to different classes of organiccompounds
• Some important physical properties of organiccompounds
• Free radical/ nucleophylic [alkyl/ acyl/ aryl] /electrophylic- substitu-
tion, free radical/ nucleophylic / electrophylic- addition, elimination,
oxidation and reduction reactions with mechanism, orientation, order
of reactivity, stability ofcompounds
• Some named organic reactions withmechanisms
• Uses of organic compounds inpharmacy.
At the end of the course the student should be able to

• name , write the structure of organiccompound
• name the type ofisomerism
• compare physical properties
• tell the name, class ofreaction
• tell the method of conversion ofcompounds
• account for reactivity, orientation ofreactions
• prepare organiccompounds
• identify, confirm the identification of organiccompound
Text books
• Organic chemistry- T.R.Morrison and R.Boyd
• Text book of Pharmaceutical chemistry - Bentley andDriver
• Organic chemistry, the fundamentals of chemistry -I.L.Finar
• Organic chemistry -P.L.Soni
• Text book of organic chemistry - B.S.Bahl and ArunBahl
26
Reference books
• Organic chemistry – J.M.Cram andD.J.Cram
• Organic chemistry-Brown
• Advanced organic chemistry- Jerry March,Wiley
• Organic chemistry- Cram and Hammered, PineHendrickson

Note:Toemphasisealsoondefinition,examples,uses inpharmacy,-
mechanisms of reactions .
Topic Hrs
Classification and Nomenclature

Different types of classification of organic compounds
• Common- IUPAC systems of nomenclature of following
classes of open chaincompounds. Hydrocarbons, halohy-
I. drocarbons, alcohols, aldehydes, ketones, carboxylic acids, 10
carboxylic acid halides, carboxylic acid amides, carboxylic
acid esters, acid anhydrides, amines, ethers
• Nomenclature of alicyclic compounds and aromatic com-
pounds(non heterocyclic)
Isomerism
• Structural isomerism, chain isomerism, positional isomer-
ism, functional isomerism, metamerism,tautomerism
II 04
• Stereo isomerism, optical isomerism, geometrical isom-
erism, specification of configuration, conformational isom-
erism
Structure and Properties
• Polar molecules, nonpolar molecules, protic mole-
cules, aprotic molecules
III. 05
• Inter molecularforces
• Melting point, boiling point of organic compounds, solubili-
ty of organic compounds
Alkanes
IV Free radical substitution reactions of alkanes- reactivity, inhibi- 03
tion. Reaction between methane, ethane, propane and halogens
Alkenes
a. i. Dehydrohalogenation reactions of alkyl
halides- kinetics, rearrangement of carbo cations,
reactivity,orientation
ii. Dehydration of alcohols reactions- kinetics, rear-
rangement of carbo cations, reactivity,orientation
V. iii. E1 versus E2reactions 08
b. Electrophylic addition
reactions of alkenes- orientation, rearrangement
of carbo cations,reactivity
c. Free radical addition reactions of alkenes-
orientation,reactivity
27
Alkyl halides
Preparation of alkyl halides from alcohols by Nucleophylic substi-
tution reactions, Nucleophylic substitution reactions of alkyl ha-
VI. 03
lides- kinetics, reactivity, rearrangement of carbocations, solvent
effect, stereochemistry.
SN1 versus SN2 reactions
Alicyclic compounds
VII. • Baeyer’s strain theory, Sachse Mohrtheory 03
• General methods ofpreparation
Dienes
Classification, stability, ease of formation of conjugated dienes,
VIII. 03
electrophylic and free radical addition reactions of conjugated
dienes
Aromatic compounds
a. Evidences in the derivation of structure of Benzene,
aromatic characters
b. i. Electrophylic substitution reactions of Benzene- nitration,
sulfonation, halogenations, reactivity of halogens, Friedel
craft’s alkylation, reactivity of alkyl halides and limitation of
IX. Friedel crafts alkylation reactions, Friedel crafts acylation 08
reactions.
ii. Classification ofsubstituents
iii. Orientation of mono substituted Benzene compounds
towards electrophylic substitutionreactions.
c. Nucleophilic aromatic substitution reactions- reactivity,
comparison with aliphatic nucleophylic substitution
reactions
Carbonyl compounds
a. Nucleophylic addition reactions, reactions between
carbonyl compounds and hydrogen cyanide, Sodium
X. bisulphite, hydroxyl amine, hydrazine, phenyl hydrazine, 06
2,4- dinitro phenyl hydrazine,alcohol
b. Aldol, crossed aldol, Cannizaro, crossed Cannizaro,
Benzoin, Perkin reactions
Carboxylic acids and derivatives
a. Acidity of carboxylic acids and effect of substituents on it.
XI. b. Nucleophylic acyl substitution reactions, esterification. 05
c. Comparison of alkyl nucleophylic substitution with

nucleophylic acyl substitution reactions
28
Amines
a. Basicity ofamines
XII. 03
b. Hoffmanns degradation of amides, diazotization reactions,
coupling reactions, replacement reactions of aromatic
diazoniumsalts
Phenols
a. Acidity ofphenols
XIII. 03
b. Kolbe’s synthesis, Riemer tiemann reactions,
pthalein reaction, Schotten Bauman reaction, Libermann’s
nitrosationreaction
Heterocyclic compounds
Classification, nomenclature of mono and bicyclic compounds,
XIV. 04
medicinal
uses of some important heterocyclic compounds
Carbohydrates
XV. 03
Classification, qualitative tests
Amino acids and proteins
a. Classification of amino acids, qualitative tests for
XVI. aminoacids 04
b. Classification, structure, colour reactions of proteins.
Qualitative tests for proteins
1.4 PHARMACEUTICAL ORGANIC CHEMISTRY(PRACTICAL)

Practical: 3 Hours/week
No of
Title of the experiment
classes
1 Recrystallisation of organic compounds 1
29
Preparation of simple non hetero cyclic organic compounds
and recrystallisation of compounds prepared.
(Minimum of 08 compounds)
Aspirin/Benzanilide/Phenyl benzoate/Acetanilide by acylation
2,4,6-Tribromo aniline/Para bromo acetanilide by halogenation
2 5-Nitro salicylic acid/Meta di nitro benzene by nitration Diben- 8
zal acetone from benzaldehyde by Claisen Schmidt Benzoic
acid from benzyl chloride by oxidation
Benzoic acid/Salicylic acid by hydrolysis
1- Phenyl azo -2- napthol from aniline by diazotization and
coupling Benzophenone oxime from benzophenone
Systematic qualitative analysis of unknown organic com-

3 2
pounds for preliminary and Lassaigns tests.
Systematic qualitative analysis of unknown organic com-
pounds for functional groups (for preliminary / Lassaigns /
solubility / functional group tests )
4 Following classes of compounds may be analysed 11
Phenols, amide/ urea, carbohydrate, amine, carboxylic acid,
aldehyde, ketone, alcohol, carboxylic acid ester, hydrocarbon,
halohydrocarbon, nitrocompound, anilide
Determination of melting and boiling points of organic com-
5 1
pounds
Preparation of suitable solid derivatives from organic com-
6 1
pounds
Introduction to the use of stereomodels – Methane,Ethane,
Ethene, Acetylene, Cyclo hexane, Benzene (Students to pre-
7 pare the ball and stick stereomodels using china clay, plastic 1
sticks individually and to explain the
formation of bonds& bond angles, bond lengths )
Course Materials :
1. Practical organic chemistry – Mann andSaunders
2. Introduction to organic laboratory techniques – Pavia, Lampman,Kriz
3. Text book of Practical Organic Chemistry -Vogel

Sessional Annual
Synopsis 04 15
Minor Experiment - 15
Viva 04 15
Max Marks 20 70
30
1.5 PHARMACEUTICAL INORGANIC CHEMISTRY(Theory)
Theory: 2 hrs/Week
1. Scope and objectives: This course mainly deals with fundamentals of

analytical chemistry and also the study the Inorganic pharmaceuticals regarding
their monographs and also the course deals with basic knowledge of analysis of
variouspharmaceuticals.
Upon completion of course student shall be able to:
• understand the principles and procedures of analysis of drugs and also
regarding the application of inorganicpharmaceutical;
• know the analysis of the inorganic pharmaceuticals theirapplications
• appreciate the importance of inorganic pharmaceuticals in
preventing and curing thedisease.
Text books
• A.H.Beckett & J.B. Stenlake’s -Practical Pharmaceutical Chemistry Vol I &
II, Stahl one Press of Deemed to be University of London, 4thedition.
• Text Book of Quantitative Inorganic analysis byVogel
• Inorganic Pharmaceutical Chemistry III-Edition P. GunduRao
Reference books
• A text book of Inorganic medicinal Chemistry by Surendra N.Pandey.
• Inorganic pharmaceutical Chemistry by M.LSchroff
• Bentely and Driver’s Textbook of Pharmaceuticalchemistry
• Pharmaceutical Analysis Vol – I, Dr. A.V. Kasture et al., Nirali
Prakashan,13th
• Edition.
• Inorganic Pharmaceutical Chemistry by Anand &Chetwal.
• Analytical chemistry principles by John H.Kennedy.
• I.P.1985 ,1996, 2008 Govt. of India, Ministry ofHealth
Topics Hrs
1. Sources of errors, types of errors, methods of minimizing errors, 02
accuracy, precision and significant figures.
2. Fundamentals of volumetric analysis, theories of indicators and 04
methods of expressing concentrations. Primary and secondary stan-
dard. Preparation and standardization of various volumetic solutions
like oxalic acid, sodium hydroxide, hydrochloric acids, sodium thio-
sulphate, sulpuric acid, potassium permanganate, iodine and cerric
ammonium sulphate solutions.
3. Acid base titration: Classification and estimation of strong, weak, 02
and very weak acids and bases.
4. Principles of redox titrations: Concepts of oxidation and reduc- 03
tion. Redox reactions, strength and equivalent weights of oxidizing
and reducing agents, theory of redox titrations, cerrimetry, Iodime-
try, Iodometry, bromometry, titrations with potassium iodate, po-
tassium bromate, titanous chloride, 2,6- dichlorophenolindophenol.
31
5. Non aqueous titration: Introduction to solvents, classification and 02
estimation of Sodium benzoate and ephedrine HCl.
Principles of precipitation titrations: Different methods-Mohr’s,

6. Modified Mohr’s, Volhard’s, Modified Volhard’s, Fajans with example. 03
Estimation of sodium chloride by modified volhards method.
Complexometric titration and its classification: Estimation of
7. Magnesium sulphate, and Calcium Gluconate by complexometric 03
method. Metal ion indicators.
Gravimetry: Introduction to gravimetric method, steps involved in
8. gravimetric method, precipitants and estimation of Barium sulphate 02
by gravimetric method.
Limit test: Source and effect of impurities in pharmacopoeial sub-
stances, importance of limit test, general principle and procedures
9. for limit test, limit test for chloride, sulphate, iron, arsenic and lead 06
and heavy metals. Special procedure for limit test for chloride and
sulphate
General methods of preparation, assays*, storage condition and Medic-
inal uses of inorganic compounds belonging to the following classes.
10. Medicinal gases: Oxygen, Nitrous oxide, Carbon dioxide 01
11. Acidifies: Dil HCl, Ammonium Chloride* 01
Antacid: Aluminum hydroxide gel*, sodium bicarbonate*, Mag-
nesium triisilicate, Magnesium carbonate (Light and Heavy), Mag-
12. 03
nesium hydroxide mixture*, Preparation containing combination
ofantacids.
13. Cathartics: Magnesium sulphate, Sodium orthophosphate 01
Major extra and intracellular electrolytes: Functions of major
physiological ions, Electrolytes used in the replacement therapy:
Sodium chloride*, Sodium chloride Injection, Sodium chloride com-
14. 04
pound injection, Potassium chloride, Potassium chloride injection,
Calcium Gluconate* and Electrolyte combination therapy and ORS,
Physiological acid base balance.
15. Essential trace elements: Copper, Iron, Iodine and Zinc 01
Antimicrobials: Potassium permanganate*, Hydrogen peroxide*,
16. 03
Chlorinated lime*, Iodine and its preparations, Boric acid*.
Pharmaceutical aids: Bentonite, sodium metabisulphite, Barium
17. 01
sulphate*
Dental products: Dentifrices, role of fluoride in the treatment of
dental caries,
18. 02
Desensitizing agents, Calcium carbonate, Sodium fluoride, Stannous
fluoride, Zinc Eugenolcement.
Miscellaneous compounds:
i) Expectorants: Potassiumiodide*
ii) Haematinics: Ferrous sulphate*, Ferrous gluconate, Ferrousfu-
19. 04
marate,
iii) Emetics: Copper sulphate*, Sodium potassiumtartarate
iv) Poison and Antidote: Sodium thoisulphate, Activatedcharcoal,
32
Radiopharmaceuticals: Radio activity, natural radio activity and
artificial radio activity. Measurement of radioactivity, Properties of α,
β, γ radiations,Half life, radio isotopes and study of radio isotopes
20. 02
sodium iodide I-121, Ferriccitrate
Fe-59. Storage conditions, precautions & pharmaceutical application
of radioactive substances.
1.5 PHARMACEUTICAL INORGANIC CHEMISTRY(PRACTICAL)

Practical: 3 Hours/week
(Following experiments to be covered in 25 different practical classes)
1. Limit tests (7 exercises)*
• Limit test forchlorides
• Limit test forsulphate
• Limit test forIron
• Limit test for heavymetals
• Limit test forArsenic
• Modifications in limit tests for chloride and sulphates in potassium
permanganate, sodium bicarbonate, sodium benzoate and sodiumSa-
licylate.
2. Preparation and standardization of the following (3 exercises)*.
• 0.IN NaOH
• 0.INKMnO4
• 0.IN Cerric ammoniumsulphate
• 0.INHClO4
• 0.05M Di sodiumEDTA
• 0.IN Sodiumthiosulphate
3. Assay of the following compounds**
• Ammonium chloride-acid base titration (Formaltitration)
• Ferrous sulphate- (redox) Ceric ammonium sulphatetitration
• Copper sulphate- (redox)Iodometry
• Calciumgluconate-complexometry
• Hydrogen peroxide- (redox-Permanganometry)
• Sodium benzoate-nonaqueoustitration
• Sodium chloride-Modified Volhard’smethod
• Assay of KI-KIO3titration
• Assay of Zinc oxide (acid base backtitration)
4. Test for identify for the following (2exercises)*
• Sodiumbicarbonate
• Ferroussulphate
• Potassiumiodide.
• Calciumchloride
5. Test for purity for the following (2exercises)*
• Swelling power inBentonite
• Ammonium salts in Potashalum.
• Presence of Iodates inKI
6. Preparation of inorganic pharmaceuticals (2exercises)*
• Boricacid
• Potashalum
• Magnesiumhydroxide.
• Magnesiumsulphate
Scheme of Practical Examination Sessional Annual
33
Synopsis 05 15
Major Experiment(Experiment indicated by**) 10 25
Minor Experiment(Experiment indicated by*) 1&2 3 20
Viva-Voce 2 10
Max. Marks 20 # 70
# Note: Total sessional marks is 30 (20 for practical sessional and 10 marks for
regularity, promptness, viva-voce and record maintenance)
1.6 REMEDIAL MATHEMATICS/BIOLOGY(THEORY)
REMEDIAL MATHEMATICS :
1. Scope and objectives: This is an introductory course in mathematics.
This subjects deals with the introduction to matrices, determinants, trigo-
nometry, analytical geometry, differential calculus, integral calculus, differ-
ential equations, laplacetransform.
Upon completion of the course the student shall be able to : –
• Know Trigonometry, Analytical geometry, Matrices, Determinant, Integra-
tion, Differential equation, Laplace transform and theirapplications;
• solve the problems of different types by applying theory;and
• appreciate the important applications of mathematics inpharmacy.
Text books
• Differential calculus ByShantinarayan
• Text book of Mathematics for second year pre-university by-
Prof.B.M.Sreenivas
Reference books
• Integral calculus ByShanthinarayan
• Engineering mathematics ByB.S.Grewal
• Trigonometry Part-I ByS.L.Loncy
Topic Hrs
1 Algebra : Matrices : Definition, Addition, Subtraction and Multipli- 18
cation of matrices, Determinants: Determinants of order two and
three, Properties of determinants (without Proof). Inverse of square
Matrices, Adjoint of square matrix, Solution of linear equation by
Matrix method, Cramer’s rule, Characteristic equation, Statement of
Cayley-Hamilton Theorem (Without Proof) – Pharmaceutical exam-
ples
2 Trigonometry : Relation between Sides andanglesof a triangle, 05
solutionof triangles – Simple problems
3 Analytical Geometry :Points, Straight line, Types of straight lines 15
– Y= mx + c, (y-y1) = m*(x-x1), (y-y1) = ((y2-y1)/(x2-x1))*(x-x1)
Parallel and Perpendicular straight lines, Angle between two lines,
Perpendicular distance from a point to the line, distance between
parallel lines, Circle: General equation of circle, finding centre and
radius of the circle, Parabola: Equation of the parabola y2= 4ax ,
Simple problems
34
4 Differential calculus: Function, Limit, Differentiation, Differentia- 16
tion of sum, Product, Quotient, Composite, Parametric, exponential,
trigonometric and Logarithmic function. Successive differentiation,
simple problems.
5 Integral Calculus: Partial fractions, Definition of integration, inte- 07
gration by substitution and integration by parts, Properties of defi-
nite integrals, Simple problems.
6 Differential equations: Definition, order, degree, variable separa- 10
ble, homogeneous differential equation, linear differential equation,
exact differential equation, Simple problems
7 Laplace transform: Definition, Laplace transform of elementary 04
functions, linearity and shifting property , simple problems
REMEDIAL BIOLOGY :
1. Scope and objectives: This is an introductory course in Biology, which
gives detailed study of natural sources such as plant and animal origin.
This subject has been introduces to the pharmacy course in order to make
the student aware of various naturally occurring drugs and its history,
sources, classification, distribution and the characters of the plants and
animals. This subject gives basic foundation toPharmacognosy.
Text books
• Text book of Biology byS.B.Gokhale
• A Text book of Biology by Dr.Thulajappa and Dr.Seetaram.
Reference books
• A Text book of Biology by B.V.SreenivasaNaidu
• A Text book of Biology by Naidu andMurthy
• Botany for Degree students ByA.C.Dutta.
• Outlines of Zoology by M.Ekambaranatha ayyer andT.N.Ananthakrishnan.
• A manual for pharmaceutical biology practical by S.B.Gokhale andC.K.Ko-
kate.
Topic Hrs
PART – A
01 Introduction 02
02 General organization of plants and its inclusions 04
03 Plant tissues 04
04 Plant kingdom and its classification 04
05 Morphology of plants 04
06 Root, Stem, Leaf and Its modifications 05
07 Inflorescence and Pollination of flowers 04
08 Morphology of fruits and seeds 04
09 Plant physiology 04
Taxonomy of Leguminosae, umbelliferae, Solanaceae, Lilliaceae,
10 Zinziberaceae, 06
Rubiaceae
11 Study of Fungi, Yeast, Penicillin and Bacteria 04
PART-B
35
01 Study of Animal cell 04
02 Study animal tissues 04
03 Detailed study of frog 08
04 Study of Pisces, Reptiles, Aves 05
05 General organization of mammals 05
06 Study of poisonous animals 04
36
1.6 REMEDIAL BIOLOGY (PRACTICAL)
Title
Introduction of biology experiments (section cutting techniques,
1.
Mounting and staini9ng, permanence slide preparation and Microscope)
2. Study of cell wall constituents and cell inclusions
3. Study of Stem modifications
4. Study of Root modifications
5. Study of Leaf modifications
6. Identification of Fruits and seeds
7. Preparation of Permanent slides
9. Simple plant physiological experiments
10. Identification of animals
11. Detailed study of Frog by using computer models
12. Computer based tutorials

Sessionals Annual
Synopsis 04 10
Viva 02 15
Max Marks 20 70
regularity, promptness, viva-voce and record maintenance.
Pharm.D.- Second Year

Sl.
Name of Subject hours of hours of hours of
No
(1) (2) (3) (4) (5)
2.1 Pathophysiology 3 - 1
2.2 Pharmaceutical Microbiology 3 3 1
Pharmacognosy & Phytopharmaceu-
2.3 3 3 1
ticals
2.4 Pharmacology-I 3 - 1
2.5 Community Pharmacy 2 - 1
2.6 Pharmacotherapeutics-I 3 3 1
Total Hours 17 9 6 = 32
2.1 PATHOPHYSIOLOGY(THEORY)
37
1. Scope and Objectives: This course is designed to impart a thorough

knowledge of the relevant aspects of pathology of various conditions with
reference to its pharmacological applications, and understanding of basic
Pathophysiological mechanisms. Hence it will not only help to study the
syllabus of pathology, but also to get baseline knowledge of its application
in other subject of pharmacy.
Upon completion of the course student shall be able to –
• Describe the etiology and pathogenesis of the selected diseasestates;
• Name the signs and symptoms of the diseases;and
• Mention the complications of thediseases.
2. Course Materials:Text books(Theory)

• Pathologic basis of disease by- Cotran, Kumar,Robbins
• Text book of Pathology- HarshMohan
• Text book of Pathology- Y.M.Bhinde
Reference books(Theory)
• Clinical Pharmacy and Therapeutics; Fourth edition; Walker & Whittlesea,
Churchill Livingstone publication
3. Lecture wiseProgramme:
Topic Hrs
1 Basic principles of cell injury and Adaptation 05
• Causes, Pathogenesi s and morphology of cellinjury
• Abnormalities in lipoproteinaemia, glycogen infiltration
and glycogen infiltration and glycogen infiltration and glyco-
gen storagediseases
2 Inflammation 05
• Pathogenesis of acute inflammation, Chemical mediators
ininflammation, Types of chronic inflammation
• Repairs of wounds in the skin, factors influencing healing
ofwounds
Diseases of Immunity
• Introduction to T and Bcells
3
• MHC proteins or transplantationantigens 02
• Immune tolerance
• Hypersensitivity Hypersensitivity type I, II, III, IV, Biological-

03
significance, Allergy due to food, chemicals anddrugs
• Autoimmunity Criteria for autoimmunity, Classifications of

autoimmune diseases in man, mechanism of autoimmunity,
Transplantation and immunologic tolerance, allograft rejec- 03
tions, transplantation antigens, mechanism of rejection of
allograft.
• Acquired immune deficiency syndrome (AIDS) 01
• Amylodosis 01
38
Cancer
Differences between benign and malignant tumors, Histological
diagnosis of malignancy, invasions and metastasis, patterns of
4 05
spread, disturbances of growth of cells, classification of tumors,
general biology of tumors, spread of malignant tumors, etiology and
pathogenesis of cancer.
Shock
5 03
Types of shock, mechanisms, stages and management
6 Biological effects of radiation 02
Environmental and nutritional diseases
i) Air pollution and smoking- SO2,NO, NO2, andCO
7 04
ii) Protein calorie malnutrition, vitamins, obesity, pathogenesis
ofstarvation.
8 Pathophysiology of common diseases
Parkinsonism 01
Schizophrenia 01
Depression and mania 02
Hypertension 02
Stroke (ischemic and hemorrhage) 02
Angina, CCF, Atherosclerosis, Myocardial infarction 08
Diabetes Mellitus 02
Peptic ulcer and inflammatory bowel diseases 04
Cirrhosis and Alcoholic liver diseases 04
Acute and chronic renal failure 02
Asthma and chronic obstructive airway diseases 02
Infectious diseases :
Sexually transmitted diseases (HIV, Syphilis, Gonorrhea), Urinary
9 tract infections, 11
Pneumonia, Typhoid, Tuberculosis, Leprosy, Malaria, Dysentery
(bacterial and amoebic), Hepatitis- infective hepatitis.
39
4. Assignments:
• Chemical Mediators ofinflammation
• DrugHypersensitivity
• Cigarette smoking & its illeffects
• Biological Effects ofRadiation
• Etiology and hazards ofobesity
• Complications ofdiabetes
• Diagnosis ofcancer
• Disorders ofvitamins
• Methods in Pathology-Laboratory values of clinicalsignificance
• Pathophysiology of Dengue Hemorrhagic Fever(DHF)
Format of the assignment
• 1 Minimum & Maximum number ofpages.
• Reference(s) shall be included at theend.
• Assignment can be a combined presentation at the end of the academic-
year
• It shall be computer draftcopy.
• Name and signature of thestudent
• Time allocated for presentation may be 8+2Min.
2.2 PHARMACEUTICAL MICROBIOLOGY(THEORY)

1. Scope & Objectives: Microbiology has always been an essen-
tial component of pharmacy curriculum. This is because of the relevance
of microbiology to pharmaceutical sciences and more specifically to phar-
maceutical industry. Pharmaceutical biotechnology is the logical extension
of pharmaceutical microbiology, which is expected to change the complete
drug product scenario in thefuture.
This course deals with the various aspects of microorganisms, its classification,
morphology, laboratory cultivation identification and maintenance. Its also dis-
cusses with sterilization of pharmaceutical products, equipment, media etc. The
course further discusses the immunological preparations, diseases its transmis-
sion, diagnosis, control and immunological tests.
Upon completion of the course student shall be able to
• Know the anatomy, identification, growth factors and sterilization ofmicro-
organisms;
• Know the mode of transmission of disease causing microorganism, symp-
toms of disease, and treatmentaspect;
• Do estimation of RNA and DNA and there by identifying thesource;
• Do cultivation and identification of the microorganisms in thelaboratory;
• Do identification of diseases by performing the diagnostic tests;and
• Depreciate the behavior of motility and behavioral characteristics ofmicro-
organisms.
2. Course Materials:
Text books(Theory)
• Vanitha Kale and Kishor Bhusari “Applied Microbiology” Himalaya Publish-
inghouse Mumbai.
• Mary Louis Turgeon “Immunology and Serology in Laboratory Medicines”
2nd edition, 1996 Mosby- Year book inc St. LouisMissouri.
• Harsh Mohan, “Text book of Pathology” 3rd edition, 1998, B-3 Ansari road
Daryaganj N. Delhi.
40
• Prescot L.M., Jarley G.P Klein D.A “Microbiology” 2nd- edition Mc GrawHill
CompanyInc.
• Rawlins E.A. “Bentley’s Text Book of Pharmaceutics” Bailliere Tindals 24-28
London1988.
• Forbisher “Fundamentals of Microbiology” Philadelphia W.B.Saunders.
• Prescott L.M. Jarley G.P., Klein D.A. “Microbiology.” 2nd edition WMC Brown
Publishers, Oxford.1993.
• WarRoitt,JonathanBrostoff,Davidmale,“Immunology”3rdedition1996,Mos-
by-year
• book Europe Ltd, London.
• Pharmacopoeia of India, Govt. of India,1996.
Topic Hrs
Introduction to the science of microbiology.
1 03
Major divisions of microbial world and Relationship among them.
Morphology & Physiology of Microorganisms
2 Different methods of classification of microbes and study of Bacte- 07
ria, Fungi, Virus, Rickettsiae, Spirochetes.
Growth & Nutrition
3 Nutritional requirements
Growth and cultivation of bacteria and virus.
08
Culture Media for aerobic and anaerobic bacteria & fungi. Mainte-
nance of lab cultures.
Isolation and Identification of Bacteria Different meth-
4 ods-Staining reactions Biochemical reactions.
08
Counting of bacteria -Total and Viable counting techniques.
Sterilization
Detailed study of different methods of sterilization with merits and
5 demerits. Sterilization methods for all pharmaceutical products.
08
Detailed study of sterility testing of different pharmaceutical prepa-
rations. Validation of various sterilization techniques.
Disinfectants
Study of disinfectants, antiseptics, fungicidal and virucidal agents.
Factors affecting their action and mechanism of action.
6
Evaluation of bactericidal, bacteriostatic, virucidal 07
and preservatives in
pharmaceutical preparations.
Immunology
Definition, Classification, General principles of natural immunity,
Phagocytosis, acquired immunity (active and passive).
Antigens, chemical nature of antigens structure and formation of
7
Antibodies, Antigen-Antibody reactions.
12
Bacterial exotoxins and endotoxins. Significance of toxoids in
active immunity, Immunization programme, and importance of
booster dose.
Diagnostic tests
8 Schick’s Test, Elisa test, Western Blot test, Southern BlotPCR
07
Widal, QBC, Mantaux Peripheral smear. Study of malarial parasite.
41
Microbiological Assays
Microbial culture sensitivity Testing: Interpretation of results Princi-
9 ples and methods of different microbiological assays.
05
Microbiological assay of Penicillin, Streptomycin and vitamin B2
and B12. Standardization of vaccines and sera.
Study of infectious diseases
10 Typhoid, Tuberculosis, Malaria, Cholera, Hepatitis, Meningitis, 10
Syphilis & Gonorrhea and HIV.
2.2 PHARMACEUTICAL MICROBIOLOGY(PRACTICAL)

Title of the Experiment:
• Study of apparatus used in experimentalmicrobiology*.
• Sterilisation of glass ware’s. Preparation and sterilisation ofmedia*
• Staining techniques – Simple staining; Gram’s staining; Negativestain-
ing**
• Study of motilitycharacters*.
• Enumeration of micro-organisms (Total andViable)*
• Study of the methods of isolation of pureculture.*
• Bio chemical testing for the identification ofmicro*-organisms.
• Cultural sensitivity testing for somemicro-organisms.*
• Sterility testing for powders andliquids.*
• Determination of minimum inhibitoryconcentration.*
• Microbiological assay of antibiotics by cup platemethod.*
• Microbiological assay of vitamins by Turbidometricmethod**
• Determination ofRWC.**
* Indicate minor experiment & ** indicate major experiment
Assignments:
• Visit to some pathological laboratories & study the activities and equip-
ment/instruments used and reporting thesame.
• Visit to milk dairies (Pasturization) and microbial laboratories (other ster-
ization methods) & study the activities and equipment/instruments used
and reporting thesame.
• Libraryassignments
a. Report of recent microbial techniques developed in diagnosing some
common diseases.
b. Latest advancement developed in identifying, cultivating & handling
of microorganisms.
Format of the assignment:

• Minimum & Maximum number ofpages.
• It shall be computer draftcopy.
• Name and signature of thestudent.
year.
42
Sessionals Annual
Synopsis 05 15
Viva 02 15
Max Marks 20 70
2.3 PHARMACOGNOSY & PHYTOPHARMACEUTICALS(THEORY)
Theory : 3 Hours/Week
1. Scope and objectives: This subject has been introduced for the
pharmacy course in order to make the student aware of medicinal uses of
various naturally occurring drugs their history, sources, distribution, meth-
od of cultivation, active constituents, medicinal uses, identification tests,
preservation methods, substitutes andadulterants.
Upon completion of the course student shall be able to:
• Understand the basic principles of cultivation, collection and storage of
crudedrugs
• Know the source, active constituents and uses of crude drugsand
• Appreciate the applications of primary and secondary metabolites of the-
plant.
Text books
• Pharmacognosy by G.E. Trease & W.C.Evans.
• Pharmacognosy by C.K. Kokate, S.B. Gokhale & A.C.Purohit.
Reference books
• Pharmacognosy by R. Brady & V.E.Tyler.
• Pharmacognosy by T.E.Wallis.
• Pharmacognosy by C.S. Shah & J.S.Quadry.
• Pharmacognosy by M.A.Iyengar.
Topics Hrs
1 Introduction. 01
2 Definition, history and scope of Pharmacognosy. 02
Classification of crude drugs viz. alphabetical, morphological,
3 chemical, pharmacological, taxonomical methods. General methods 05
of chemotaxonomy.
Cultivation, collection, processing and storage of crude drugs. Con-
4 05
servation of medicinal plants.
Detailed method of cultivation of crude drugs.
5 a) Senna b) Cinchona c) Cardamom d) Opium e) Isapgol f) Ergot 06
h) Ginger
43
6 Study of cell wall constituents and cell inclusions. 04
Study of morphology and microscopy of different plants parts.
i. Leaf:Datura,Senna ii. Bark: Cinnamon (Cassia),Cin-
chaona
7 iii.Wood:Quassia iv. Stem:Ephedra
v. Root:Rauwolfia, Liquorice vi. Rhizome: Ginger,Podophyllum. 10
vii. Flowerbuds:Clove. viii. Fruits: Coriander, Fennel ix .
Seeds: Isapgol, NuxVomica.
Study of naturalpesticides.
8 03
Pyrethrum, Neem,Tobacco
Detailed study of various plantconstituents.
• Detailed study of Carbohydrates andrelatedproducts.
• Biological source, method of production, chemical constit-
9 uents, tests, uses and adulterants of i) Honey ii) Acacia iii) 10
Agar iv) Sterculia v)Tragacanth vi) Cellulose and its products
vii) Pectin viii) Guar gum ix) Sodium alginate.

• a) Definition, sources, method extraction, chemistry and
method of analysis of Lipids.
• Study of method of production, chemical constituents, tests, 02
10 usesand adulterants of the followingdrugs.
• i)Castor oil ii) Shark liver oil iii) Chaulmoogra oil iv) Wool fat 05
v)Beeswax vi) Spermaceti vii) Cocoa butter viii) Olive oil
Therapeutic application of herbal drugs, poisonous plants, herb-

11 al-drug interaction, edible vaccines, marine Pharmacognosy. 04
Introduction, definition, classification, general properties, chemical

12 tests and general method of isolation of Alkaloids, Glycosides, Es- 12
sential Oils,Flavonoids, ResinsandTannins.
13 Study of plants fibers used in surgical dressings andrelatedproducts. 04
Different methods of adulteration of crude drugs and gen-

eralmethods of detection of adulterants.
02
2.3 PHARMACOGNOSY & PHYTOPHARMACEUTICALS(PRACTICAL)
General Requirements: Laboratory Napkin, Observation Book (150 pages), Zero
brush, Needle, Blade, Match box.
List of experiments:
• Introduction of Pharmacognosy laboratory andexperiments.
• Macro, powder and microscopic study ofDatura.
• Macro, powder and microscopic study ofSenna.
• Macro, powder and microscopic study of CassiaCinnamon.
• Macro, powder and microscopic study ofCinchona
• Macro, powder and microscopic study ofEphedra.
• Macro, powder and microscopic study ofQuassia.
• Macro, powder and microscopic study ofClove
44
• Macro, powder and microscopic study ofFennel.
• Macro, powder and microscopic study ofCoriander.
• Macro, powder and microscopic study ofIsapgol.
• Macro, powder and microscopic study of Nuxvomica.
• Macro, powder and microscopic study ofRauwolfia.
• Macro, powder and microscopic study ofLiquorice.
• Macro, powder and microscopic study ofGinger.
• Macro, powder and microscopic study ofPodophyllum.
• Determination of Iodinevalue.
• Determination of Saponification value and unsoponifiablematter.
• Determination of Acidvalue.
• Chemical tests for Acacia andTragacanth
• Chemical tests for Agar andStarch
• Chemical tests forGelatin
• Chemical tests for Lipids (Castor oil, Sesame oil, Shark Liver oil, Bees-
wax).
• Determination of moisture content of crudedrug.
• Isolation of Volatileoil.

Sessionals Annual
Synopsis 04 10
Viva 02 15
Max Marks 20 70
Duration 03 hrs 04 hrs
2.4 PHARMACOLOGY – I(THEORY)

1. Scope & Objectives: This subject will provide an opportunity for
the student to learn about the drug with regard to classification, phar-
macodynamic and pharmacokinetic aspects, adverse effects, uses, dose,
route of administration, precautions, contraindications and interaction with
other drugs. In this subject, apart from general pharmacology, drugs act-
ing on autonomic nervous system, cardiovascular system, central nervous
system, blood and blood forming agents and renal system will be taught.

• Understand the pharmacological aspects of drugs falling under the above
mentioned chapters.
• Handle and carry out the animalexperiments.
• Appreciate the importance of pharmacology subject as a basis oftherapeu-
tics.
• Correlate and apply the knowledge therapeutically.
45
Text books (Theory)
• Tripathi, K. D. Essentials of medical pharmacology. 6th edition, 2008. Pub-
lisher: Jaypee,Delhi.
• Satoskar,R.S.andBhadarkar,S.D.Pharmacologyandpharmacotherapeu-
tics.20th
• edition, 2008. Publisher: Popular, Mumbai.
• Rang, H.P. & Dale, M.M. Pharmacology. 5h edition, 2003. Publisher: Chur-
chill Living stone.

• Goodman Gilman, A., Rall, T.W., Nies, A.I.S. and Taylor, P. Goodman and
Gilman’s The pharmacological basis of therapeutics. 11th edition, 2006.
Publisher McGraw Hill, PergamonPress.
• Craig, C.R. & Stitzel, R.E. Modern Pharmacology. 5th edition, 1997. Pub-
lisher: Little BrownCo.
• Katzung,B.G.Basicandclinicalpharmacology.9thedition,2004.Publisher:Pren-
tice Hall, Int.
• Shargel and Leon. Applied Biopharmaceutics and Pharmacokinetics. Latest
edition 2002. Publisher: Prentice Hall,London.
3. Lecture wise Programme:

Topics Hrs
General Pharmacology
• Introduction, definitions and scope ofpharmacology
• Routes of administration ofdrugs
• Pharmacokinetics (absorption, distribution, metabolism
andexcretion)
1. • Pharmacodynamics 16
• Factors modifying drugeffects
• Drug toxicity – Basic concepts, acute, sub-acute and
chronictoxicity.
• Pre-clinicalevaluation
• Druginteractions
Note: The term Pharmacology used here refers to the classification, mechanism
of action, pharmacokinetics, pharmacodynamics, adverse effects, contraindica-
tions, therapeutic uses, interactions and dose and route of administration.
Pharmacology of drugs acting on ANS
• Introduction toneurotransmission
• Adrenergic and antiadrenergicdrugs
• Cholinergic and anticholinergicdrugs
2. 09
• Neuromuscularblockers
• Mydriatics andmiotics
• Drugs used in myastheniagravis
• Drugs used inParkinsonism
Pharmacology of drugs acting on cardiovascular system
• Antihypertensives
• Anti-anginaldrugs
3. 09
• Anti-arrhythmic drugs
• Drugs used for therapy of Congestive HeartFailure
• Drugs used forhyperlipidaemias
46
Pharmacology of drugs acting on Central Nervous System
• Excitatory and inhibitory neurotransmitters ofCNS
• Generalanesthetics
• Sedatives andhypnotics
• Anticonvulsants
• Analgesic and anti-inflammatoryagents
4. 20
• Psychotropic drugs
• Alcohol and methylalcohol
• CNS stimulants and cognitionenhancers
• Centrally acting skeletal musclerelaxants
• h) Drug dependence, abuse and tolerance. List of drugs
causing such problems
5. Pharmacology of Local anaesthetics 02
Pharmacology of Drugs acting on Respiratory tract
• Bronchodilators
• Mucolytics
6. 05
• Expectorants
• Antitussives
• NasalDecongestants
Pharmacology of Hormones and Hormone antagonists
• Thyroid and Antithyroiddrugs
7. • Insulin, Insulin analogues and oral hypoglycemicagents 08
• Sex hormones and oralcontraceptives
• Oxytocin and other stimulants and relaxants
Pharmacology of autocoids and their antagonists

• Histamines andAntihistaminics
8. 06
• 5-Hydroxytryptamine and itsantagonists
• Lipid derived autocoids and platelet activatingfactor
47
2.5 COMMUNITY PHARMACY(THEORY)
1. Scope & Objecives: This course is designed to ensure that stu-

dents are skilled and knowledgeable to provide various pharmaceutical
care services to patients and general practitioners in the communitysetup.
Upon completion of the course, the student shall be able to –
• Handle the prescriptions and manage the communitypharmacies
• Deliver the pharmaceutical care services in the community pharmacies.
• Respond to minor ailments and provide healtheducation
• Promote rational drugtherapy.
2. Course Materials:TextBooks:
• Health Education and Community Pharmacy byN.S.Parmar.
• WHO consultative groupreport.
• Drug store & Business management by Mohammed Ali &Jyoti.
Reference books:
• Handbook of pharmacy – health care. Edt. Robin J Harman. The Pharma-
ceuticalPress.
• Comprehensive Pharmacy Review – Edt. Leon Shargel. Lippincott Williams
&Wilkins.
Special requirements:
• Either the college is having model community pharmacy (meeting the
schedule N requirement) or sign MoU with at least 4-5 community phar-
macies nearby to the college for training the students on dispensing and
counselingactivities.
• Special equipments like Sphygmomanometer, Glucometer, Peak flow me-
ter, and apparatus for cholesterolestimation.
Topic Hrs
Definition and scope of community pharmacy
1. 02
Roles and responsibilities of Community pharmacist
Community Pharmacy Management
a) Selection of site, Space layout, anddesign
b) Staff, Materials- coding,stocking
2. 04
c) Legalrequirements
d) Maintenance of variousregisters
e) Use of Computers: Business and health care softwares
Prescriptions – parts of prescription, legality & identification of
3. 02
medication related problems like drug interactions.
Inventory control in community pharmacy
4. Definition, various methods of Inventory Control 03
ABC, VED, EOQ, Lead time and safety stock
Pharmaceutical care
5. 02
Definition and Principles of Pharmaceutical care.
48
Patient counseling
Definition, outcomes, various stages, barriers, strategies to over-
6. 04
come barriers Patient information leaflets- content, design, layouts
& advisory labels
Patient medication adherence

7. Definition, Factors affecting medication adherence and role of 02
pharmacist in improving the adherence
Health screening services

8. Definition, importance, methods for screening blood pressure/ 03
blood sugar/ lung function and Cholesterol testing
OTC Medication - Definition, OTC medication list & Counsel-

9. 03
ling
Health Education
10. WHO Definition of health and health promotion, care for children,
pregnant & breast feeding women and geriatricpatients. 02
Commonly occurring communicable diseases, causative agents,
Clinical presentations and prevention of
11. communicable diseases – 09
Tuberculosis, Hepatitis, Typhoid, Amoebiasis, Malaria, Leprosy,
Syphilis, Gonorrhea and AIDS
12. Balance diet, treatment & prevention of deficiency disorders 02
13. Family planning – role of pharmacist 01
Responding to symptoms of minor ailments
Relevant pathophysiology and common drug therapy to Pain, GI
14. 08
disturbances (Nausea, Vomiting, Dyspepsia, diarrhea, constipa-
tion), Pyrexia, Opthalmic symptoms and worms infestations.
Essential Drugs concept and Rational Drug Therapy Role of

15. 02
community pharmacist
16. Code of ethics for community pharmacists 01
2.6 PHARMACOTHERAPEUTICS-I
1. Scope and Objectives: This course is designed to impart knowledge and

skills necessary for contribution to quality use of medicines. Chapters dealt
cover briefly pathophysiology and mostly therapeutics of various diseases.
This will enable the student to understand the pathophysiology of common
diseases and theirmanagement.
At completion of this course it is expected that students will be able to understand:

• The pathophysiology of selected disease states and the rationale for
drugtherapy
• The therapeutic approach to management of thesediseases
• The importance of preparation of individualized therapeutic plans based
ondiagnosis
• Needs to identify the patient-specific parameters relevant in initiating drug
49
therapy, and monitoring therapy (including alternatives, time-course of
clinical and laboratory indices of therapeutic response and adverseeffects)
• Describe the pathophysiology of selected disease states and explain the
rationale for drug therapy
• Summarise the therapeutic approach to management of these diseases
including reference to the latest availableevidence
• Discuss the controversies in drugtherapy
• Discuss the preparation of individualised therapeutic plans based ondiag-
nosis
• Identify the patient-specific parameters relevant in initiating drug therapy,
and monitoring therapy (including alternatives, time-course of clinical and
laboratory indices of therapeutic response and adverseeffects)
2. Coursematerials
TEXTBOOKS
• Clinical Pharmacy and Therapeutics – Walker and Whittlesea, Churchill
Livingstone publication
• Pharmacotherapy: A Pathophysiology approach - Joseph T. Dipiro et al.
Appleton &Lange
REFERENCE BOOKS
• Pathologic basis of disease : Robbins SL, W.B. Saunderspublication
• Pathology and therapeutics for Pharmacists: A Basis for Clinical Pharmacy
Practice-
• Green and Harris, Chapman and Hall publication
• Clinical Pharmacy and Therapeutics - Eric T. Herfindal, Williams and Wilkin-
sPublication
• AppliedTherapeutics:TheclinicalUseofDrugs.LloydYoungandKoda-KimbleMA,
• Williams and Wilkins Publication
• Avery’s Drug Treatment, 4th Edn, 1997, Adis InternationalLimited.
• Relevant review articles from recent medical and pharmaceuticalliterature.
3. Lecture wiseProgramme
Etiopathogenesis and pharmacotherapy of diseases associated with fol-
lowing systems/ diseases
Title Hrs
Cardiovascular system Hypertension, Congestive cardiac failure,
1. Angina Pectoris, Myocardial infarction, , Hyperlipidemia , Electro- 13
physiology of heart andArrhythmias
Respiratory system
2. Introduction to Pulmonary function test, Asthma, Chronic obstruc- 06
tive airways disease, Drug induced pulmonary diseases
Endocrine system
3 Diabetes, Thyroid diseases, Oral contraceptives, Hormone replace- 08
ment therapy, Osteoporosis
General prescribing guidelines for

Paediatric patients
4 04
• Geriatric patients
• Pregnancy and breastfeeding
50
5 Ophthalmology: Glaucoma, Conjunctivitis- viral & bacterial 03
Introduction to rational drug use
6 Definition, Role of pharmacist in promoting rational drug use and 02
essential drug concept.
2.6 PHARMACOTHERAPEUTICS-I (PRACTICAL)

Hospital postings in various departments designed to complement the lectures by
providing practical clinical discussion; attending ward rounds; follow up the prog-
ress and changes made in drug therapy in allotted patients; case presentation
upon discharge. Students are required to maintain a record of cases presented and
the same should be submitted at the end of the course for evaluation. A minimum
of 15 cases should be presented and recorded covering most common diseases.
ASSIGNMENTS
Students are required to submit written assignments on the topics given to them.
Topics allotted should cover recent developments in drug therapy of various dis-
eases. A minimum of THREE assignments [1500 – 2000 words] should be submit-
ted for evaluation.
Assignments
- Minimum & Maximum number of pages. - It shall be computer draft copy
- Reference(s) shall be included at the
- Name and signature of the student
end.
- Assignment can be a combined presen- - Time allocated for presentation
tation at the end of the academic year may be 8+2 min
Scheme of Practical Examination

Sessionals Annual
Synopsis 05 15
Viva 02 15
Max Marks 20 70
* Total sessional marks is 30 (20 for practical sessional plus 10 marks for regular-
ity, promptness, viva-voce and record maintenance)
51
Pharm. D. - Third Year
Sl.
Name of Subject hours of hours of hours of
No.
(1) (2) (3) (4) (5)
3.1 Pharmacology-II 3 3 1
3.2 Pharmaceutical Analysis 3 3 1
3.3 Pharmacotherapeutics-II 3 3 1
3.4 Pharmaceutical Jurisprudence 2 - -
3.5 Medicinal Chemistry 3 3 1
3.6 Pharmaceutical Formulations 2 3 1
PHARMACOLOGY – II (THEORY)
1. Scope and Objectives: This subject will provide an opportunity for

the student to learn about the drug with regard to classification, phar-
macodynamic and pharmacokinetic aspects, adverse effects, uses, dose,
route of administration, precautions, contraindications and interaction with
other drugs. In this subject, drugs acting on autacoids, respiratory sys-
tem, GIT, immune system, hormones, pharmacology of autocoids and dif-
ferent aspects of genes will be concentrated. In addition, pharmacology of
chemotherapeutic agents and principles of toxicology are also taught. In
addition to theoretical knowledge, the basic practical knowledge relevant
to therapeutics will beimparted.
Upon completion of the subject student shall be able to:

• Understand the pharmacological aspects of drugs falling under the above
mentioned chapters.
• Carry out the animal experimentsconfidently.
• Appreciate the importance of pharmacology subject as a basis oftherapeu-
tics.
• Correlate and apply the knowledge therapeutically.
• Understand different aspects of genes and their regulatoryfunctions.
Text books(Theory)
• Tripathi, K. D. Essentials of medical pharmacology. 6th edition, 2008. Pub-
lisher: Jaypee, Delhi.
• Satoskar, R.S. and Bhadarkar, S.D. Pharmacology and pharmacotherapeu-
tics. 20th edition (single volume), 2008. Publisher: Popular,Mumbai.
• Rang, H.P. and Dale, M.M. Pharmacology. 5th edition, 2003. Publisher:
Churchill Living stone.
• Alberts, B., Bray, D., Lewis, J., Raff M., Roberts, K and Watson, JD Molecu-
lar Biology of the Cell by, 5rd edition, 2008, Publisher: GarlandScience.
52
• Goodman Gilman, A., Rall, T.W., Nies, A.I.S. and Taylor, P. Goodman and
Gilman’s The pharmacological basis of therapeutics. 11th edition, 2006.
Publisher: McGraw Hill, Pergamonpress.
• Craig, C.R. and Stitzel, R.E. Modern Pharmacology. 5th edition 1997. Pub-
lisher: Little Brown andcompany.
• Katzung, B.G. Basic andclinical pharmacology. 9th edition 2004. Publisher:
Prentice Hall,
• International.
• Gupta, P.K. and Salunkhe, D.K. Modern Toxicology. Volume I, II and III.
1985.Publisher:
• B.V. Gupta, Metropolitan Book Co. (p) Ltd, New Delhi.
• Crommelin, DJA and Sindelar RD. Pharmaceutical Biotechnology. 3rd edi-
tion 2008. Publisher: InfarmaHealthcare.
• Watson, JD., Gilman, M., et al. Recombinant DNA. 2nd edition 1992. Pub-
lisher: Scientific
• America.
• Walsh, G. Biopharmaceutical: Biochemistry and Biotechnology. 2nd edition
2007. Publisher: JohnWily.
• Derelanko MG. Handbook of toxicology. 2nd edition 2002; Publisher: CRC-
Press.
Text books (Practical)

• a Kulkarni, S. K. and Dandia, P. C. Hand book of experimental pharmacolo-
gy. Latest edition, Publisher: Vallab, Delhi.
Reference books (Practical)

• Macleod, L.J. Pharmacological experiments on intact preparations. Latest
edition, 1970, Publisher: Churchilllivingstone.
• Macleod, L.J. Pharmacological experiments on isolated preparations. Latest
edition, 1970, Publisher: Churchilllivingstone.
• Ghosh, M.N. Fundamentals of experimental pharmacology. 3rd edition,
2005; Publisher: Scientific book agency,Kolkata.
• Ian Kitchen. Textbook of in vitro practical pharmacology. 1984. Publisher:
Black well Scientific.
Topics Hrs
Pharmacology of drugs acting on Blood and blood forming
agents
1. • Anticoagulants 06
• Thrombolytics and antiplateletagents
• Haemopoietics and plasmaexpanders
Pharmacology of drugs acting on Renal System
2. • Diuretics 03
• Antidiuretics
Pharmacology of drugs acting on Gastrointestinal Tract
• Antiulcer drugs,Antacids
3 • Laxatives and purgatives 06
• Emetics and antiemetics
• Appetizers, digestants andcarminatives
53
Chemotherapy
• Introduction
• Sulfonamides and co-trimoxazole
• Penicillins andCephalosporins
• Tetracyclins andChloramphenicol
• Macrolides, Aminoglycosides, Polyene & Polypeptideantibiot-
ics
4. • Quinolines and Fluroquinolines 22
• Antifungalantibiotics
• Antiviralagents
• Chemotherapy of tuberculosis andleprosy
• Chemotherapy ofMalaria
• Chemotherapy of protozoal infections (amoebiasis,giardiasis)
• Pharmacology of Anthelminticdrugs
• Chemotherapy of cancer(Neoplasms)
Immunopharmacology
5 03
• Pharmacology of immunosuppressants and stimulants
Principles of Animal toxicology

• Acute, subacute and chronictoxicity.
6. 02
• Principles involved in the various toxicity screening methods
available for drugs in the laboratoryanimals.
The dynamic cell: The structures and functions of the com-
ponents of the cell
• Cell and macromolecules: Cellularclassification, subcellular
organelles, macromolecules, large macromolecularassemblies
• Chromosome structure: Pro and eukaryotic chromosome
structures, chromatin structure, genome complexity, the flow
of geneticinformation.
7. • DNA replication: General, bacterial and eukaryotic DNArepli- 11
cation.
• The cell cycle: Restriction point, cell cycle regulators and-
modifiers.
• Cell signaling: Communication between cells and their envi-
ronment, ion- channels, signal transduction pathways (MAP
kinase, P38 kinase, JNK, Ras and PI3-kinase pathways,bio-
sensors.
54
The Gene: Genome structure and function:
• Gene structure: Organization and elucidation of geneticcode.
• Gene expression: Expression systems (pro and eukaryotic),
genetic elements that control gene expression (nucleosomes,
histones, acetylation, HDACS, DNA binding proteinfamilies.
• Transcription and Transcription factors: Basic principles of
transcription in pro and eukaryotes. Transcription factors that
regulate transcription in pro andeukaryotes.
• RNA processing: rRNA, tRNA and mRNAprocessing.
8 • Protein synthesis: Mechanisms of protein synthesis, initiation 18
in eukaryotes, translation control and post-translationevents
• Altered gene functions: Mutations, deletions, amplifications,
LOH, translocations, trinucleotide repeats and other genetic
abnormalities. Oncogenes and tumor suppressorgenes.
• The gene sequencing, mapping and cloning of human dis-
easegenes.
• Introduction to gene therapy andtargeting.
• Recombinant DNA technology: principles. Processes
(gene transfer technology) andapplications
Bio-assay methods
9 • Scope, principles involved in general methods, bioassay de- 04
signing, applications and limitations.
3.1 PHARMACOLOGY – II(PRACTICAL)
Practical: 3Hrs./Week
1. Study of laboratory animals and their handling (a. Frogs, b. Mice, c. Rats,
d. Guinea pigs, e. Rabbits).
2. Study of physiological salt solutions used in experimentalpharmacology.
3. Study of laboratory appliances used in experimentalpharmacology.
4. Study of use of anesthetics in laboratoryanimals.
5. To record the dose response curve of Acetylcholine using isolated rat ile-
um/rectus abdominis musclepreparation.
6. To carry out bioassay of Ach using isolated rat ileum/rectus abdominis
muscle preparation by interpolationmethod.
7. To carry out bioassay of Ach using isolated ileum/rectus abdominis muscle
preparation by three pointmethod.
8. To record the dose response curve of Histamine using isolated guinea-pig
ileumpreparation.
9. To carry out bioassay of Histamine using isolated guinea-pig ileum prepa-
ration by interpolation method.
10. To carry out bioassay of Histamine using guinea-pig ileum preparation by
three pointmethod.
11. Study of agonistic and antagonistic effects of drugs using isolated guin-
ea-pig ileumpreparation.
12. To study different routes of administration of drugs in animals (Rats,
Mice,Rabbits).
13. Study of theory, principle, procedure involved and interpretation of given
results for the following experiments:
• Analgesic property of drug using analgesiometer (tail flick andhot-
55
plate).
• Antiinflammatory effect of drugs using rat-paw edemamethod.
• Anticonvulsant activity of drugs using maximal electroshock and pen-
tylene tetrazolemethods.
• Antidepressant activity of drugs using pole climbingapparatus.
• Pentobarbitone induced sleeping time inmice.
• Locomotor activity of drugs usingactophotometer.
• Cardiotonic activity of drugs using isolated frog heart and mammalian
heartpreparations.
• Skeletal muscle relaxant activity of the drugs usingrotarod.
• Drugs effect on the blood pressure, heart rate and respiratory rate
ofdog.
14. Simulatedexperiments
• Effect of drugs on frog’s isolatedheart.
• Effect of drugs on rabbiteye.
• Effect of drugs on ciliary motility of frog’sesophagus.

Session-
Annual
als
Synopsis 04 10
Major Experiment (Bioassay) 08 30
Minor Experiment
04 10
(Interpretation of given Graph/ simulated experiment)
Viva 02 10
Max Marks 20 70
Duration 3hrs 4hrs
3.2 PHARMACEUTICAL ANALYSIS(THEORY)
1. Scope and objectives: This course is designed to impart a fundamental

knowledge on the art and science of testing drugs by various instrumental
methods of analysis. This focuses on various modern instruments that are
used for testing the purity of drugs in various dosage forms. This course
also gives idea about modern instruments that are used for drug testing
like NMR, IR, Mass, HPLC, HPTLC forms. etc,. It prepares the students for
most basics of the applied field ofpharmacy.
At the end of course, students are able
• To understand the construction and working of various analyticalinstru-
ments.
• To know principle and mechanism ofinstrumentation.
• To understand the different modern techniques of druganalysis.
• To appreciate the advantages of instrumental methods of druganalysis.
56
Text books
• Instrumental methods of analysis by Willard, Merrit, Dean and Settlle
6thedition
• Practical Pharmaceutical Chemistry Vol-II- Beckett and Stenlake 3rdedition
Reference books
• Text book of quantitative chemical analysis by A.I.Vogel
• Text book of Pharmaceutical Analysis by K.A.Cannors
• Pharmaceutical analysis by Skoog andWest.
• William Kemp- Spectroscopymethods.
Quality Assurance:
• Introduction, sources of quality variation, control of quality-
1 variation. 03
• Validation methods- quality of equipment, validation of equip-
ment and validation of analytical instruments andcalibration.
Chromatography: Introduction, history, classification, separation
techniques, choice of methods. The following techniques be discussed
2
with relevant examples of pharmaceutical products involving princi-
ples and techniques of separation of drugs from excipients.
• Column Chromatography: Adsorption column chromatography,
Operational technique, frontal analysis and elution analysis.
03
Factors affecting column efficiency, applications and partition
chromatography.
• TLC: Introduction, principle, techniques, Rf value and applica-
02
tions.
• PC: Introduction, principle, types of paper chromatography,
02
preparation techniques, development techniques, applications.
• Ion-exchange chromatography: Introduction, principles, types
of ion exchange synthetic resins, physical properties, factors 03
affecting ion exchange, methodology andapplications.
• HPLC: Introduction, theory, instrumentation, and applications. 03
• HPTLC: Introduction, theory, instrumentation, and applica-
02
tions.
• Gas Chromatography: Introduction, theory, instrumenta-
tion-carrier gases, types of columns, stationary phases in GLC
& GSC. Detectors-Flame ionization detectors, electron capture
04
detector, thermal conductivity detector. Typical gas chromato-
gram,derivatisationtechniques,programmedtemperaturegas
• chromatography, applications.
• Electrophoresis: Principles of separation, equipment for paper

02
and gel electrophoresis, and application
• Gel filtration applications. and affinity chromatography: In-
03
troduction, technique,
3 Electrometric Methods: Theoretical aspects, instrumentation,

interpretation of data/spectra and analytical applications be dis-
cussed on the following topics.
57
• Potentiometry: Electrical potential, electrochemical cell, refer-
ence electrodes, indicator electrodes, measurement of poten-
tial and pH, construction and working of electrodes, Potentio- 05
metric titrations, methods of detecting end point, Karl
• Fischer titration.
• Conductometry: Introduction, conductivity cell, conductomet-
03
ric titrations and applications.
• Amperometric Titrations: Introduction, types of electrodes
used, referenceand indicator electrode, instrumentation, ti-
04
tration procedure, advantages and disadvantages of
Amperometry over Potentiometry. Pharmaapplications.
4. Spectroscopy: Theoretical aspects, instrumentation, elements of
interpretation of data/spectra and application of analytical tech-
niques be discussed on:
a. Absorption Spectroscopy: Theory of electronic, atomic and
molecular spectra. Fundamental laws of photometry, Beer-Lambert’s
Law, application and its deviation, limitation of Beer law, application
of the law to single and multiple component analysis, measurement
08
of equilibrium constant and rate constant by spectroscopy. Spectra
of isolated chromophores, auxochromes, batho-chromic shift, hyp-
sochromic shift, hyperchromic and hypochromic effect, effect of sol-
vent on absorption spectra, molecular structure and infrared spectra.
Instrumentation – Photometer, U.V.-Visible spectrophotometer
– sources of U.V.- Visible radiations, collimating systems, mono-
chromators, samples cells and following detectors-Photocell, Barrier 05
layer cell, Phototube, Diode array, applications of U.V.-Visible spec-
troscopy in pharmacy and spectrophotometric titrations.
Infrared Spectroscopy: Vibrational transitions, frequency – struc-
ture correlations, Infrared absorption bands, Instrumentation–IR
spectro-meter – sources of IR, Collimating systems, monochroma-
06
tors, sample cells, sample handling in IR spectroscopy and detec-
tors–Thermocouple, Golay Cells, Thermistor, Bolometer,
Pyroelectric detector, Applications of IR in pharmacy.
Fluorimetric Analysis: Theory, luminescence, factors affecting
fluorescence, quenching. Instrumentation, Applications, fluorescent
04
indicators, study of pharmaceutically important compounds estimat-
ed by fluorimetry.
b. Flame Photometry: Theory, nebulisation, flame and flame tem-
perature, interferences, flame spectrometric techniques and 04
instrumentation and pharmaceuticalapplications.
c. Atomic Absorption Spectrometry: Introduction, Theory, types
of electrodes, instrumentation and applications.
d. Atomic Emission Spectroscopy: Spectroscopic sources, atomic
02
emission spectrometers, photographic and photoelectric detection.
e. NMR (introduction only):Introduction,theoretical aspects and
02
applications
f. Mass Spectroscopy: (Introduction only) – Fragmentation,
02
types of ions produced, mass spectrum andapplications.
58
3.2 PHARMACEUTICAL ANALYSIS(PRACTICAL)
1. Separation and identification of Amino Acids by PaperChromatography*.
2. Separation and identification of Dyes by radial paperchromatography*.
3. Separation and identification of Sulpha drugs by TLCtechnique*.
4. Effect of pH and solvent on the UV spectrum of givencompound*.
5. Determination of dissociation constant of indicators using UV-Visible
spectroscopy*.
6. Conductometric titration of mixture of acids with a strongbase**.
7. Potentiometric titration of strong acid with a strongbase**.
8. Estimation of drugs by Fluorimetrictechnique**.
9. Study of quenching effect influorimetry**.
10. Colorimetric estimation of Supha drugs using BMRreagent**.
11. Simultaneous estimation of two drugs present in givenformulation**.
12. Assay of Dextrose bycolorimetry**
13. Colorimetric estimation of Ferrous ions using1,10-Phenonthroline**.
14. UV spectroscopic estimation of Paracetamoltablets*
15. Determination of Chlorides and Sulphates in Calcium gluconate by Neph-
eloturbidimetric Method**.
16. Determination of Na/K by FlamePhotometry**.
17. Determination of pKa using pHmeter*.
18. Infrared spectral graphs/ peak identiofication of samples with different-
functional groups (-COOH, -COOR, -NH2, -NHR, -OH, -CHO,-C=O)
19. Demonstration ofHPLC.
SCHEME OF PRACTICAL EXAMINATION:

Sessional Annual
Synapses 05 10
Major Experiment(Experiment indicated by**) 10 30
Minor Experiment(Experiment indicated by*) 3 20
Viva-Voce 2 10
Max. Marks 20# 70
#Note: Total sessional marks is 30 (20 for practical sessional and 10 marks for
3.3 PHARMACOTHERAPEUTICS-II
Upon completion of the course student shall be able to
• know the pathophysiology of selected disease states and therationale for
drug therapy
• know the therapeutic approach to management of thesediseases
• know the controversies in drugtherapy
59
• knowtheimportanceofpreparationofindividualised therapeuticplansbasedon-
diagnosis
• identify the patient-specific parameters relevant in initiating drug therapy,
2. Course Materials:Text books(Theory)

• Clinical Pharmacy and Therapeutics - Walker and Whittlesea, Churchill Liv-
ingstone publication

• Pharmacotherapy: A Pathophysiologic approach - Joseph T. Dipiro et al.
Appleton & Lange
• Clinical Pharmacy and Therapeutics - Eric T. Herfindal, Williams and
Wilkins Publication
• Applied Therapeutics: The clinical Use of Drugs. Lloyd Young andKo-
da-Kimble
3. Lecture wiseprogramme
lowing systems / diseases
No. Topics Hrs

Infectious diseases: Guidelines for the rational use of antibiot-
ics and surgical Prophylaxis, Tuberculosis, Meningitis, Respiratory
tract infections, Gastroenteritis, Endocarditis, Septicemia, Urinary
1. 18
tract infections, Protozoal infection- Malaria, HIV & Opportunistic
infections, Fungal infections, Viral
infections, Gonorrhoea and Syphilis
Musculoskeletal disorders
2 Rheumatoid arthritis, Osteoarthritis, Gout, Spondylitis, System- 06
ic lupus erythematosus.
Renal system
3 Acute Renal Failure, Chronic Renal Failure, Renal Dialysis, Drug 05
induced renal disorders
Oncology: Basic principles of Cancer therapy, General intro-
duction to cancer chemotherapeutic agents, Chemotherapy
4 06
of breastcancer, leukemia. Management of chemotherapy induced
nausea andemesis
5 Dermatology: Psoriasis, Scabies, Eczema, Impetigo 04
60
3.3 PHARMACOTHERAPEUTICS-II(PRACTICALS)
Hospital postings for a period of at least one month is required to understand the
principles and practice involved in ward round participation and clinical discussion
on selection of drug therapy. Students are required to maintain a record of 15
cases observed in the ward and the same should be submitted at the end of the
course for evaluation.
ASSIGNMENTS
ted forevaluation.

- Minimum & Maximum number of
- It shall be computer draft copy
pages.
end.
- Assignment can be a combined pre- - Time allocated for presentation may
sentation at be
the end of the academic year 8+2 min

Sessionals Annual
Synopsis 05 15
Viva 02 15
Max Marks 20 70
* Total sessional marks is 30 (20 for practical sessional plus 10 marks for
3.4 PHARMACEUTICAL JURISPRUDENCE(THEORY)

1. Scope and Objectives: This course exposes the student to several
important legislations related to the profession of pharmacy in India. The
Drugs and Cosmetics Act, along with its amendments is the core of this
course. Other acts, which are covered, include the Pharmacy Act, danger-
ous drugs, medicinal and toilet preparation Act etc. Besides this the new
drug policy, professional ethics, DPCO, patent and design Act will bedis-
cussed.
Upon completion of the subject student shall be able to (Know, do, and appreciate)
• practice the Professionalethics;
• understand the various concepts of the pharmaceutical legislation inIndia;
• know the various parameters in the Drug and Cosmetic Act andrules;
61
• know the Drug policy, DPCO, Patent and designact;
• understand the labeling requirements and packaging guidelines for drugs
andcosmetics;
• be able to understand the concepts of Dangerous Drugs Act, Pharmacy Act
and Excise duties Act; and
• other laws as prescribed by the Pharmacy Council of India from time to
time including InternationalLaws.
2. Course materialsText books(Theory)

• Mithal , B M. Textbook of Forensic Pharmacy. Calcutta :National; 1988.
• Singh, KK, editor. Beotra’s the Laws of Drugs, Medicines & cosmetics.Allahabad:
• Law Book House; 1984.
• Jain, NK. A Textbook of forensic pharmacy. Delhi: Vallabh prakashan ;1995.
• Reports of the Pharmaceutical enquiryCommittee
• I.D.M.A., Mumbai. DPCO1995
• Various reports ofAmendments.
• Deshapande, S.W. The drugs and magic remedies act 1954 and rules
1955. Mumbai: Susmit Publications;1998.
• Eastern Book Company .The narcotic and psychotropic substances act
1985, Lucknow: Eastern;1987.
3. Detailed syllabus and lecture wiseschedule:
Topic Hrs
Pharmaceutical Legislations – A brief review.
• Introduction, Study of drugs enquiry committee, Health sur-
1. 02
vey and development committee, Hathi committee and Mu-
daliar committee
Code of Pharmaceutical ethics
2. • Definition, Pharmacist in relation to his job, trade, medical 02
profession and his profession, Pharmacist’s oath
Drugs and Cosmetics Act, 1940 and its rules 1945.

• Objectives, Definitions, Legal definitions of schedules to the
act andrules
• Import of drugs – Classes of drugs and cosmetics prohibited
fromimport, Import under license or permit. Offences andpen-
alties.
• Manufacture of drugs – Prohibition of manufacture and sale of
certain drugs, Conditions for grant of license and conditions
of license for manufacture of drugs, Manufacture of drugs for
test, examination and analysis, manufacture of new drug, loan
3. license and repackinglicense. Detailed study of schedule M, N 22
and Y. Offences andpenalties
• Sale of Drugs – Wholesale, Retail sale and Restricted license.
Offences and penalties
• Labeling & Packing of drugs- General labeling requirements
andspecimen labels for drugs and cosmetics, List of permitted
colors. Offences and penalties
• Administration of the act and rules – Drugs Technical Advisory
Board, Central drugs Laboratory, Drugs Consultative Commit-
tee, Government analysts, Licensing authorities, controlling
authorities, DrugInspectors
62
Pharmacy Act –1948.
• Objectives, Definitions, Pharmacy Council of India; its consti-
4. tution and functions, Education Regulations, State and Joint 05
state pharmacy councils; its constitution and functions, Reg-
istration of Pharmacists, Offencesand Penalties.
Medicinal and Toilet Preparation Act –1955.
• Objectives, Definitions, Licensing, Manufacture In bond and
5. Outside bond, Export of alcoholic preparations, Manufacture 04
of Ayurvedic, Homeopathic, Patent & Proprietory Preparations.
Offences and Penalties.
• Narcotic Drugs and Psychotropic substances Act-1985
and Rules. Objectives, Definitions, Authorities and Officers,
Constitution and Functions of narcotic & Psychotropic
6. Consultative Committee, National Fund for Controlling the 04
Drug Abuse,Prohibition, Control and Regulation, opiumpoppy
cultivation and production of poppy straw, manufacture, sale
and export of opium, Offences and Penalties
• Study of Salient Features of Drugs and magic reme-
dies Act and its rules. Objectives, Definitions, Prohibition of
7. 02
certain advertisements, Classes of Exempted advertisements,
Offences and Penalties
Drug Price control Order & National Drug Policy(Current).
• Objectives, Definitions, Sale prices of bulk drugs, Retail price
of formulations, Retail price and ceiling price of scheduled for-
8. 02
mulations, Implementation of prices Fixed/revised.
• Pharmaceutical Policy 2002: Objectives,Approaches in the re-
view, Salient features of Pharmaceutical Policy 2002.
Prevention Of Cruelty to animals Act-1960.
• Objectives, Definitions, Institutional Animal Ethics Committee,
Breeding and Stocking of Animals, Performance of Experi-
9.
ments, Transfer and acquisition of animals for experiment,
Records, Power to suspend or revoke registration, Offences 03
and Penalties
Patents & design Act-1970.
• Objectives, definitions, Types of patent, PCT, Patentable and
not patentable inventions, Applications for patents, Term of
10. patent, revocation of patents, compulsory licensing, Offences
andpenalties.
• Registration of designs, copyright, prohibition of certain de- 03
signs, cancellation of designs, Offences andpenalties.
11. Brief study of prescription and Non-prescription Products. 01
63
4. Assignments:
• Minimum & Maximum number ofpages
• It shall be a computer draftcopy
year.
• Time allocated for presentation may be 8+2Min
Case studies relating to
• Drugs and Cosmetics Act and rules along with its amendments, Dangerous
Drugs Act, Medicinal and Toilet preparation Act, New Drug Policy, Profes-
sional Ethics, Drugs (Price control) Order, Patent and DesignAct.
• Various prescription and non-prescriptionproducts.
• Medical and surgicalaccessories.
• Diagnostic aids and appliances available in themarket.
3.5 MEDICINAL CHEMISTRY(THEORY)
1. Scope and Objectives: This course is designed to impart a fundamen-

tal knowledge on the structure and functions of the different drugs. The
course gives details of Chemistry, Mechanism of action, metabolism, ad-
verse effects, Structure Activity Relationships (SAR) and uses of Chemo-
therapeutic Agents, Cardiovascular Drugs and synthesis of some important
drugs. The course also covers modern techniques of drug design, which
include Prodrug concept and combinatorialchemistry.
At the end of the course, students are able

• To understand the chemistry of drugs with respect to their biologicalactivi-
ty.
• To know the metabolism, adverse effect and therapeutic activity ofdrugs.
• To understand the different modern techniques of drugdesign.
• To appreciate the SAR of some important drug classes.
Text books
• Wilson and Giswolds, Text book of Organic and pharmaceuticalchemistry
• Principles of Medicinal chemistry- William O.Foye
Reference books
• A I Vogel Text book of Practical OrganicChemistry
• Text Book of organic chemistry by I. L.Finar
• S.N. Pandeya, A Text Book of Medicinal Chemistry, S.G. Publisher, Varana-
si, Vol I& II.
Topic Hrs
64
• Modern concept of rational drug design: A brief introduction
I to prodrug & drug latentiation, combinatorial chemistry, gen- 04
eral pathways & factors affecting drug metabolism.
• A study of the development of the following classes ofdrug-
sincluding SAR, mechanism of action, synthesis of important
II
compounds (marked with asteric*), brand names of import-
ant marketed products and their side effects.
1 Anti-infective agents: 15
• Local anti-infectiveagents: Alcohols: isopropyl alcohol Phe-
nols: cresols, hexyl resorcinol Cationic surfactants: benzalko-
nium chloride, cetyl pyridinium bromide Nitrofurans: nitrofu-
razone, furazolidone.
• Antifungalagents: Azoles: miconazole, ketoconazole, fluco-
nazole Miscellaneous: tolnaftate, naftifine Antifungal Antibiot-
ics: amphotericin, nystatin, griseofulvin.
• Urinary tract anti-infectives: SAR of quinolone antibacterial
agents, Norfloxacin, ciprofloxacin*, sparfloxacin, ofloxacin,
• Antitubercular agents: Management of tuberculosis, Synthet-
ic anti TB agents: INH*, Pyrizinamide, ethambutol,
• Anti TB antibiotics: rifampin, capreomycin
• Antiviral agents and Anti AIDS agents: amantadine, acyclovir,
trifluridine, zidovudine, stavudine
• Antiprotozoal agents: Introduction to protozoal diseases and
causative organisms. Metronidazole, diloxanide furoate, de-
hydroemetine, nifurtimox
• Anthelmentics: Benzimidazoles: mebendazole, albendazole
Piperazine, diethylcarbamazine, ivermectin
Sulfonamides and sulfones

History and development of sulfonamides, SAR and mechanism of
action of Sulfonamides, pKa of Sulfas and Crystalluria. Sulfame-
2 05
thoxazole, sulfisoxazole, sulfacetamide*, sulfasalzine Folate reduc-
tase inhibitors: trimethoprim*, synergistic action of cotrimoxazole.
Sulfones: dapsone
Antimalarials: Etiology of malaria, SAR and mechanism of action
of quinoline Antimalarials Quinine sulphate, Chloroquine phosphate,
3 05
amodiaquine, pamaquine*, primaquine, Quinacrine
Chloroguanide, cycloguanil, pyrimethamine
65
Antibiotics
Historical background and classification of antibiotics.
Beta lactam antibiotics: development of acid resistant and extended
spectrum Penicillins. Penicillin G, ampicillin, amoxicillin, cloxacillin
Beta lactamase inhibitors: clavulanic acid, thienamycin Cephalospo-
4 rins: cephelexin, cefadroxil, cefuroxime 12
Aminoglycosids: streptomycin, neomycin, amikacin, gentamicin
Tetracyclines: Chemistry and SAR of tetracyclines, chlortetracycline,
doxycycline, Minocycline.
Macrolides: erythromycin, azithromycin
Miscellaneous: clindamycin, bacitracin, chloramphenicol*
66
Antineoplastic agents
Historical background and classification of antineoplastic agents Al-
kylating agents: cyclophosphamide, mechlorethamine, cholrambucil
5. Antimetabolites: mercaptopurine, flurouracil, methotrexate Antibi- 06
otics: dactinomycin, mitomycin, streptozocin
Plant products: etoposide, taxol, vincristine and vinblastine Miscel-
laneous: cisplatin, interferons
Cardiovascular agents
• Antianginal agents and vasodilators Nitrovasodilators: amyl
nitrite, isosorbide dinitrate Calcium channel blockers: ver-
apamil, diltiazem
• Antiarrhythmic agents:
Class I: quinidine, phenytoin, lidocaine, encainide
Class II: beta blockers- propranolol
Class III: amiodarone
6 Class IV: Calcium channel blockers: verapamil, diltiazem 12
• Antihypertensive agents: betablockers: propranolol*, ACE
inhibitors: captopril, enalapril Angiotensin antagonists: losar-
tan Calcium channel blockers: nifedipine, amlodepine Adren-
ergic agents: clonidine, methyl dopa Adrenergic antagonists:
prazosin, reserpine
• Antihyperlipidemic agents: types of hyperlipoproteinemia
clofibrate, fenofibrate, cholestyramine, lovastatin,simvastatin
• Anticoagulants: warfarin, dicumarol,anisindione
Hypoglycemic agents:
History, development and SAR of sulfonylureas: tolbutamide*,
7. chlorpropamide, glipizide Metaglinides:repaglinide Thiazolindiones: 03
rosiglitazone, pioglitazone Biguanides: metformin, phenformin Mis-
cellaneous: acarabose, miglitol
Thyroid and Antithyroid agents

8. L-thyroxine, L-threonine 01
Propyl thiouracil, methimazole
Diuretics: Carbonic anhydrase inhibitors: acetazolmide*

Thiazide diuretics: SAR of thiazide diuretics, chlorthiazide, benz-
9. thiazide, xipamide, chlorthalidoneLoop diuretics: frusemide*, eth- 05
acrynic acidPotassium sparing diuretics: spiranolactone,amiloride
Miscellaneous: mannitol
Diagnostic agents
10. Iodipamide, diatriazoate sodium 02
Amino hippurate, sulfobromphthalein, fluorescein sodium
Steroidal Hormones and Adrenocorticoids

Estrogens: estradiol, DES
11 05
Progestines: progesterone, norethindrone Testosterone, nandralone
Betamethasone, prednisolone, beclomethasone
3.5 MEDICINAL CHEMISTRY(PRACTICAL)
67
Practical: 3 Hrs./Week
List of ex periment No of
classes
Assays of important drugs from the course content.
• Assay of ascorbic acid bycerimetry
• Assay of metronidazole byNAT
• Assay of chloroquine phosphate byNAT
A. • Assay of dapsone bydiazotization 8
• Assay of INH bybromometry
• Assay of benzyl penicillin byiodometry
• Assay of analgin byiodimetry
• Assay of diclofenac byalkalimetry
Preparation of medicinally important compounds or in-
termediates required for synthesis of drugs
• Preparation of 7-hydroxy 4-methylcoumarin
• Preparation of phenytoin frombenzoin
• Preparation of phenothiazine from diphenylamine
• Preparation of benzyl alcohol frombenzaldehyde
• Preparation ofchlorbutanol
• Preparation of eosin fromresorcinol
B. 10
• Preparation of fluorescein fromeosin
• Preparation of triphenyl imidazole frombenzoin
• Preparation of 2,3 diphenyl quinoxaline fromOPDA
• Preparation of benztriazole fromOPDA
• Preparation of benzimidazoles fromOPDA
• Preparation of sulfanilamide fromacetanilide
• Preparation ofINH
• Preparation of cinnamicacid
Monograph analysis of important drugs.
• Monograph analysis ofibuprofen
• Monograph analysis ofaspirin
C. 5
• Monograph analysis ofcaffeine
• Monograph analysis ofsulfanilamide
• Monograph analysis ofparacetamol
• Determination of partition coefficients, dissociation con-
D. 2
stants of drug substances.
Sessionals Annual
Synopsis 04 10
Assay/Estimation 06 30
Preparation 06 20
Viva 04 10
Max Marks 20 70
*Total sessional marks is 30 (20 for practical sessional plus 10 marks for
regularity, promptness, viva-voce and recordmaintenance)
68
3. 6 PHARMACEUTICAL FORMULATIONS (THEORY)
1. Scope and Objective: Scope and objectives of the course: Subject deals
with the formulation and evaluation of various pharmaceutical dosage-
forms.
Upon completion of the course student shall be able to (Know, do, appreciate) –
• understand the principle involved in formulation of various pharmaceutical
dosage forms;
• prepare various pharmaceuticalformulation;
• perform evaluation of pharmaceutical dosage forms;and
• understand and appreciate the concept of bioavailability and bioequiva-
lence, their role in clinicalsituations.
2. Course materials
Text books(Theory)
• Pharmaceutical dosage forms, Vol, I, II and III by Liberman &Lachman
• Rowlings Text book ofPharmaceutics
• Tutorial Pharmacy – Cooper &Gun
• Remington’s PharmaceuticalSciences
• USP/BP/IP
3. Lecture wiseprogramme:Title of the topic

Topic Hrs
1. Pharmaceutical dosage form- concept and classification 03
Tablets: Formulation of different types of tablets, tablet excipients,
granulation
2. 10
techniques, Tablet coating, Type of coating, quality control tests and
evaluation for uncoated and coated tablets.
Capsules: Production and filling of hard gelatin capsules, Raw ma-
terials for shell, finishing. Production and filling of soft gelatin cap-
3. sules, Importance of 07
base adsorption, quality control tests for hard and soft gelatin cap-
sules.
Liquid orals: Formulation, Manufacturing and evaluation of sus-
pensions,
4. 06
emulsions and solutions. Instability problems in suspensions and
emulsions.
Parenterals: Definition, types, advantages and limitation, general
formulation, vehicles, production procedure, production facilities,
and controls. Formulation of injections, sterile powders, implants
5. and long acting parenterals, emulsions 10
and suspensions. Containers and closures pertinent to sterile prepa-
rations and Pharmacopoeial quality control tests, Sterilization and
evaluation.
69
Semi – Solids: Introduction and classification Factors affecting
absorption, Packaging, storage and labeling.
6. 06
Ointments: Types of Ointment Base Preparation of ointment. Gels:
Types and formulation of Gels
Definition and concept of Controlled and novel Drug delivery
systems with available examples, viz. transdermal, buccal, vaginal,
7. 08
nasal, implantable, ocular
drug delivery systems
3.6 PHARMACEUTICAL FORMULATIONS(PRACTICAL)

Practical: 3 Hrs./Week
1. Manufacture of Tablets
• Ordinary compressed tablet-wet granulation
• Tablets prepared by directcompression.
• Soluble tablet.
• Chewable tablet.
2. Formulation and filling of hard gelatincapsules
3. Manufacture ofparenterals
• Ascorbic acidinjection
• Calcium gluconateinjection
• Sodium chlorideinfusion.
• Dextrose and Sodium chloride injection/infusion.
4. Evaluation of Pharmaceutical formulations (QCtests)
• Tablets
• Capsules
• Injections
5. Formulation of two liquid oral preparations and evaluation byassay
• Solution: ParacetamolSyrup
• Antacid suspensions- Aluminum hydroxidegel
6. Formulation of semisolids and evaluation byassay
• Salicyclic acid and benzoic acidointment
• Gel formulation Diclofenacgel
7. Cosmetic preparations
• Lipsticks
• Cold cream and vanishingcream
• Clear liquidshampoo
• Tooth paste and toothpowders.
8. Tablet coating(demonstration)
Scheme of PracticalExamination:
Sessionals Annual
Synopsis 05 15
Viva 02 15
Max Marks 20 70
70
Pharm. D. - Fourth Year
No. of hours of
No. of
Sl. Practical/ No. of hours
Name of Subject hours of
No. Hospital Post- of Tutorial
Theory
ing
(1) (2) (3) (4) (5)

Pharmacotherapeu-
4.1 3 3 1
tics-III
4.2 Hospital Pharmacy 2 3 1
4.3 Clinical Pharmacy 3 3 1
Biostatistics & Re-
4.4 2 - 1
search Methodology
Biopharmaceutics &
4.5 3 3 1
Pharmacokinetics
4.6 Clinical Toxicology 2 - 1
Pharmacotheraputics I
4.7 3* 3* 1*
& II*
Total hours 15/18* 12/15* 6/7 = 33/40*
4.1 PHARMACOTHERAPEUTICS -III


• The pathophysiology of selected disease states and the rationale for drug
therapy
• The therapeutic approach to management of thesediseases
• The importance of preparation of individualised therapeutic plans based
ondiagnosis
clinical and laboratory indices of therapeutic response and adverseeffects)
rationale for drug therapy
• Summarize the therapeutic approach to management of these diseases
including reference to the latest availableevidence
• Discuss the controversies in drugtherapy
71
• Discuss the preparation of individualised therapeutic plans based ondiagnosis
2. CourseMaterials:
TEXTBOOKS
• Clinical Pharmacy and Therapeutics - Roger and Walker, Churchill Living-
stone publication
Appleton & Lange
REFERENCE BOOKS
• Pathologic basis of disease - Robbins SL, W.B.Saunderspublication

• PathologyandTherapeuticsforPharmacists-ABasisforClinicalPharmacyPrac-
tice-
• Green and Harris, Chapman and Hall publication
Wilkins Publication
• Applied Therapeutics : The clinical Use of Drugs. Lloyd Young and Ko-
da-KimbleMA
• Avery’s Drug Treatment - 4th Edn, 1997, Adis InternationalLimited.

Topic Hrs
Gastrointestinal system: Peptic ulcer disease, Gastro Esopha-
geal Reflux Disease, Inflammatory bowel disease, Liver disorders
1. 20
- Alcoholic liver disease, Viral hepatitis including jaundice, and
Drug induced liver disorders.
Haematological system: Anaemias, Venous thromboembo-

2 12
lism, Drug induced blooddisorders.
Nervous system: Epilepsy, Parkinsonism, Stroke, Alzheimer’s

3 16
disease,
Psychiatrydisorders: Schizophrenia,Affective disorders, Anxi-
4 14
ety disorders, Sleep disorders, Obsessive Compulsivedisorders
Pain management including Pain pathways, neuralgias, head-
5 08
aches.
6 Evidence Based Medicine 05
72
4.1 PHARMACOTHERAPEUTICS – III(PRACTICAL)
Practicals:
Hospital postings for a period of at least 50 hours is required to understand the
principlesand practice involved in ward round participation and clinical discussion
on selection of drug therapy. Students are required to maintain a record of 15
cases observed in the ward and the same should be submitted at the end of the
course for evaluation. Each student should present at least two medical cases they
have observed and followed in thewards.
Assignments:
ted forevaluation.
Format of the assignment:

• Minimum & Maximum number ofpages
year
• It shall be computer draftcopy
Scheme of Practical Examination :

Sessionals Annual
Synopsis 05 15
Viva 02 15
Max Marks 20 70
4.2 HOSPITAL PHARMACY(THEORY)
1. Scope and Objectives: In the changing scenario of pharmacy practice in

India, for successful practice of Hospital Pharmacy, the students are re-
quired to learn various skills like drug distribution, drug dispensing, manu-
facturing of parenteral preparations, drug information, patient counseling,
and therapeutic drug monitoring for improved patientcare.
Upon completion of the course, the student shall be able to –

• Know Various Drug DistributionMethods;
• Know The Professional Practice Management Skills In HospitalPharmacies;
73
• Provide Unbiased Drug Information To TheDoctors;
• Know The Manufacturing Practices Of Various Formulations In Hospital
SetUp;
• Appreciate The Practice Based Research Methods;And
• Appreciate the stores management and inventorycontrol.
Text books: (latest editions)

• Hospital pharmacy by William .E.Hassan
• A text book of Hospital Pharmacy by S.H.Merchant & Dr.J.S.Qadry. Revised
by R.K.Goyal & R.K.Parikh
References:
• WHO consultative groupreport.
• R.P.S. Vol.2. Part –B; Pharmacy Practicesection.
• Handbook of pharmacy – health care. Edt. Robin J Harman. The Pharma-
ceuticalpress.
Topics Hrs
1 Hospital - its Organisation and functions 01
Hospital pharmacy-Organisation and management
a) Organizational structure-Staff, Infrastructure & work load-
2 statistics 05
b) Management of materials andfinance
c) Roles & responsibilities of hospitalpharmacist
3 The Budget – Preparation and implementation 01
Hospital drug policy
a) Pharmacy and Therapeutic Committee(PTC)
b) Hospitalformulary
c) Hospitalcommittees
4 12
- Infectioncommittee
- Research and ethicalcommittee
d) Development of therapeuticguidelines
e) Hospital pharmacy communication -Newsletter
5 Hospital pharmacy services
a) Procurement & warehousing of drugs and Pharmaceuticals 02
b) Inventory control: Definition, various methods of Inventory
03
Control ABC, VED, EOQ, Lead time and safety stock
c) Drug distribution inthehospital
i) Individual prescription method
03
ii) Floor stockmethod
iii) Unit dose drug distributionmethod
d) Distribution of Narcotic and other controlled substances 02
e) Central sterile supply services – Role of pharmacist 02
6 Manufacture of Pharmaceutical preparations 12
a) Sterile formulations – large and small volume parenterals 03
74
b) Manufacture of Ointments, Liquids, and creams 03
c) Manufacturing of Tablets, granules, capsules, and powders 03
d) Total parenteral nutrition 03
Continuing professional development programs
7 02
Education and training
8 Radio Pharmaceuticals – Handling and packaging 03
9 Professional Relations and practices of hospital pharmacist 02
4.2 HOSPITAL PHARMACY(PRACTICAL)

• Assessment of drug interactions in the givenprescriptions
• Manufacture of parenteral formulations andpowders.
• Drug informationqueries.
• Inventorycontrol
List of Assignments:
• Design and Management of Hospital pharmacy department for a 300 bed-
dedhospital.
• Pharmacy and Therapeutics committee – Organization, functions, andlimi-
tations.
• Development of a hospital formulary for 300 bedded teachinghospital
• Preparation of ABC analysis of drugs sold in one month from thepharmacy.
• Different phases of clinical trials with elements to beevaluated.
• Various sources of drug information and systematic approach to provide
unbiased drug information.
• Evaluation of prescriptions generated in hospital for drug interactions and
find out the suitablemanagement.
Special requirements:
• Each college should sign MoU with nearby local hospital having mini-
mum150 beds for providing necessary training to the students’ on hospital
pharmacy activities.
• Well equipped with various resources of druginformation.

Sessionals Annual
Synopsis 05 15
Viva 02 15
Max Marks 20 70
75
4.3 CLINICALPHARMACY
1. Scope and Objectives: This course is designed to impart the basic

knowledge and skills that required for practice of pharmacy including
provision of various clinical pharmacy services to patients and healthcare
professionals in clinicalsettings.
Upon completion of the course, student shall be able to

• Monitor drug therapy and resolve drug relatedproblems
• Counsel the patients for safe and effective use ofmedications
• Assist healthcare professionals in detecting and managing medication er-
rors including ADR
• Provide unbiased drug and poison informationservices
• Interpret, analyze and correlate the labinvestigations
2. Course MaterialsText books(Theory)

• Practice Standards and Definitions, The Society of Hospital Pharmacists
ofAustralia.
• Basic skills in interpreting laboratory data, Scott LT, American Society of
Health System PharmacistsInc.
• Biopharmaceutics and Applied Pharmacokinetics, Leon Shargel,
Prentice Hall Publication
• Textbook of Clinical Pharmacy Practice; Essential concepts and skills, Dr.
G.Parthasarathi, Karin Nyfort-Hansen, Milap Nahata, Orient Longman Pvt.
Ltd.
Reference Books
• Australian drug information -Procedure manual. The Society of Hospital
Pharmacists of Australia.
• Clinical Pharmacokinetics - Rowland and Tozer, Williams and WilkinsPubli-
cation.
• Pharmaceutical statistics. Practical and clinical applications. Sanford
Bolton, Marcel Dekker,Inc.
Topic Hrs
1. Definitions, development and scope of clinical pharmacy 03
76
Introduction to daily activities of a clinical pharmacist
a. Drug therapy monitoring (medication chart review, clinical
review, pharmacist interventions)
b. Ward roundparticipation
c. Adverse drug reactionmanagement
2. 13
d. Drug information and poisonsinformation
e. Medicationhistory
f. Patientcounselling
g. Drug utilisation evaluation (DUE) and review(DUR)
h. Quality assurance of clinical pharmacyservices
Patient data analysis

• The patient’s case history, its structure and use in evaluation of
3. 03
drug therapy & understanding common medical abbreviations and
terminologies used in clinical practices.
Clinical laboratory tests used in the evaluation of
disease states, and interpretation of testresults
• Haematological, Liver function, Renal function, thyroid function-
tests
4. 15
• Tests associated with cardiacdisorders
• Fluid and electrolytebalance
• Microbiological culture sensitivitytests
• Pulmonary FunctionTests
5. Drug & Poison information 08
• Introduction to drug information resourcesavailable
• Systematic approach in answering DIqueries
• Critical evaluation of drug information andliterature
• Preparation of written and verbalreports
• Establishing a Drug InformationCentre
• Poisons information- organization & informationresources
• Pharmacovigilance
Scope, definition and aims of pharmacovigilance
• Adverse drug reactions - Classification, mechanism, predisposing
6 factors, causality assessment [different scalesused], 10
• Reporting, evaluation, monitoring, preventing & management
ofADRs
• Role of pharmacist in management ofADR.
• Communication skills, including patient counseling techniques,
7 10
medication history interview, presentation ofcases.
8 • Pharmaceutical careconcepts 04
9 • Critical evaluation of biomedicalliterature 06
10 • Medicationerrors 03
4.3 CLINICAL PHARMACY(PRACTICALS)

Students are expected to perform 15 practical in the following areas covering the
topics dealt in theory class.
Answering drug information questions (4 Nos)

Patient medication counselling (4 Nos)
77
Case studies related to laboratory investigations (4 Nos)
Patient medication history interview (3 Nos)
ASSIGNMENT
Students are expected to submit THREE written assignments (1500 – 2000
words) on the topics given to them covering the following areas dealt in
theory class.
Drug information, Patient medication history interview, Patient medication coun-
seling, Problem solving in Clinical Pharmacokinetics, Therapeutic drug monitoring
and Critical appraisal of recently published articles in the biomedical literature
which deals with a drug or therapeuticissue.
- Minimum & Maximum number of pag-
- It shall be computer draft copy
es.
end.
tation at the end of the academic year. may be 8+2 min
4.4 BIOSTATISTICS AND RESEARCH METHODOLOGY(THEORY)

1. Scope and Objective : This is an introductory course in statistics,
research methodology and Computer application in hospital and commu-
nity Pharmacy. This subject deals with Research methodology, Biostatics,
epidemiology and Computer application and clinicalstudies. Research
methodology deal about types of clinical study, designing, sample size de-
termination and power of study Statistics deals about frequency distribu-
tion, graphics, averages, measures of dispersion, Correlation, regression,
Parametric and non-parametric tests. Incidence and prevalence, relative
risk, attributable risk Computer Application deals with application of Com-
puter System in Hospital Pharmacy and Community Pharmacy
Upon completion of the course the student shall be able to :

• Know the various statistical methods to solve different types ofproblems
• Operate various statistical softwarepackages
• appreciate the importance of Computer in hospital and Community Phar-
macy
• appreciate the statistical technique in solving the pharmaceuticalproblems
2. Course material:
Reference books:
• Pharmaceutical statistics- Practical and clinical applications, Sanford
Bolton3rdand 4th edition, publisher Marcel Dekker Inc.NewYork.
• Drug Information- A Guide for Pharmacists, Patrick M Malone, Karen L
Kier, John E Stanovich , 3rd edition, McGraw Hill Publications2006
• Computer Application in Pharmacy – William E. Fassett, publisher – Lea &
Febiger . Philadelphia
78
01 Topic
Hrs
ResearchMethodolo gy
• Types of clinical study designs: Case studies, obser-
vationalstudies, interventional studies,
• Designing themethodology
• Sample size determination and Power of a study,
10
Determination of sample size for simple comparative
experiments, determination of sample size to obtain
a confidence interval of specified width, power of a
study
• Report writing and presentation of data
02 Biostatistics
a) Introduction
b) Types of datadistribution
c) Measures describing the central tendency distributions-av-
2.1 10
erage, median,mode
d) Measurement of the spread of data-range, meandeviation,
standard deviation, variance, coefficient of variation, standard
error of mean.
Data graphics : Construction and labeling of graphs, histo-
2.2 gram, Pie 02
charts, scatter plots, semi-logarithmic graphs
Basics of testing hypothesis :
a) Null hypothesis, level of significance, power of test, P
value, statistical estimation of confidenceintervals.
b) Level of significance (Parametric data)- students t test
(paired and unpaired), chi Square test, Analysis of Variance
(one-way and two- way)
2.3 15
c) Level of significance (Non-parametric data)- Sign test,
Wilcoxan’s signed rank test, Wilcoxan rank sum test, Mann Whit-
ney U test, Kruskal-Wall’s test (one wayANOVA)
d) Linear regression and correlation- Introduction, Pear-
son’s and Spearman’s correlation and correlationco-efficient.
e) Introduction to statistical software: SPSS, Epi Info,SAS.
Statistical methods in epidemiology

2.4 05
Incidence and prevalence, relative risk, attributable risk
79
Computer applications in pharmacy Computer System in
Hospital Pharmacy:
Patterns of Computer use in Hospital Pharmacy – Patient record
database management, Medication order entry – Drug labels and
list – Intravenous solution and admixture, patient medication
profiles, Inventory control, Management report & Statistics.
03 Computer In Community Pharmacy 08

Computerizing the Prescription Dispensing process
Use of Computers for Pharmaceutical Care in community phar-
macy Accounting and General ledger system
Drug Information Retrieval & Storage :

Introduction – Advantages of Computerized Literature Retrieval,
Use of Computerized Retrieval
80
4.5 BIOPHARMACEUTICS AND PHARMACOKINETICS(THEORY)

skills necessary for dose calculations, dose adjustments and to apply bio-
pharmaceutics theories in practical problem solving. Basic theoretical dis-
cussions of the principles of biopharmaceutics and pharmacokinetics are
provided to help the students’ to clarify theconcepts.
At completion of this course it is expected that students will be able to -
• Define the basic concepts in biopharmaceutics andpharmacokinetics.
• Use raw data and derive the pharmacokinetic models and parameters the
best describe the process of drug absorption, distribution, metabolism an-
delimination.
• Critically evaluate biopharmaceutic studies involving drug productequiva-
lency
• Design and evaluate dosage regimens of the drugs using pharmacokinetic
and biopharmaceutic parameters.
• Detect potential clinical pharmacokinetic problems and apply basic phar-
macokinetic principles to solvethem
2. CourseMaterialsTextBooks
• Biopharmaceutics and Clinical Pharmacokinetics by, MiloGibaldi.
• Biopharmaceutics and Pharmacokinetics; By Robert FNotari
• Applied biopharmaceutics and pharmacokinetics, Leon Shargel and Andrew
B.C.YU4th edition, Prentice-Hall Inernational edition.USA
• Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar
and Sunil B.Jaiswal, Vallabh Prakashan Pitampura, Delhi
Reference Books
• Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel Dekker Inc.
• Hand Book of Clinical Pharmacokinetics, By Milo Gibaldi and Laurie
Prescott by ADIS Health SciencePress.
• Biopharmaceutics; BySwarbrick
• Cilincal Pharmacokinetics, Concepts and Applications: By Malcolm Rowlan-
dand
• Thomas, N. Tozen, Lea and Febrger, Philadelphia,1995.
• Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack, Pub-
lishing Company, Pennsylvania1989.
• Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th edi-
tion Revisedand
• expanded by Rebort F Notari Marcel Dekker Inn, New York and Basel,
1987.
• Remington’s Pharmaceutical Sciences, By Mack Publishing Company,Penn-
sylvnia
Topics Hrs
I Biopharmaceutics
1 Introduction to biopharmaceutics 01
81
Absorption; Mechanisms of drug absorption through GIT, factors
2 influencing drug absorption though GIT, absorption of drug from Non 08
per OS extra-vascular routes
Distribution of drugs Tissue permeability of drugs, binding of
drugs, apparent volume of drug distribution, protein binding of
3 08
drugs, factors affecting protein – drug binding. Kinetics of protein
binding, Clinical significance of protein bin-drug binding.
Drug Elimination. Biotransformation of drugs, renal excretion of
4 drugs , factors affecting renal excretion of drugs, renal clearance, 06
Non renal routes of drug excretion of drugs
Bioavailability and Bioequivalence: Objectives of bioavailability
studies, absolute and relative bioavailability, measurement of bio-
5 availability, in-vitro drug dissolution models, in-vitro in-vivo correla- 10
tions, bioequivalence studies, methods to enhance thebioavailabili-
ty.
II Pharmacokinetics
Introduction to Pharmacokinetics. Mathematical model. Drug levels
6 in blood. Pharmacokinetic models, Compartment models, Noncom- 05
partment models, physiological models
One compartment open model. a. Intravenous Injection (Bolus)
7 b. Intravenous infusion. c. extra vascular administrations, calcula- 15
tions of Ka, KE. From plasma and urinary excretiondata
Multicompartment models: Two
8 compartmentopen model. IV bolus, IV infusion and oraladminis- 08
tration
Multiple – Dosage Regimens: a). Repititive Intravenous injections
– One Compartment Open Model b). Repititive Extravascular dosing
9 05
– One Compartment Open model c). Multiple Dose Regimen –
Two Compartment OpenModel
Nonlinear Pharmacokinetics. a. Introduction, b. Factors causing
10 Non-linearity. 05
c. Michaelis-menton method of estimating parameters
Noncompartmental Pharmacokinetics. Statistical Moment Theo-
11 ry,. MRT for various compartment models.Physiological Pharmacoki- 04
netic model
82
4.5 BIOPHARMACEUTICS AND PHARMACOKINETICS (PRACTICAL)
List of experiments
Improvement of dissolution characteristics of slightly soluble drugs by
1.
co-solvency
Improvement of dissolution characteristics of slightly soluble drugs by sol-
2.
id dispersion
Improvement of dissolution characteristics of slightly soluble drugs by use
3.
of surfactant
Comparison of dissolution studies of two different marketed products of
4.
same drug.
5. Influence of polymorphism on solubility and dissolution
6. Protein binding studies of a drug.
7. Calculation of bioavailability
Calculation of Ka, Ke, t1/2, Cmax, AUC, AUMC, MRT etc. from blood profile
8.
data.
9. Calculation of bioavailability from urinary excretion data for two drugs.

Calculation of elimination half-life for different drugs by using urinary
elimination data
10.
and blood level data
11. Calculation of AUC and bioequivalence from the given data for two drugs
12. Absorption studies in animal inverted intestine using various drugs.
Studying metabolic pathways for different drugs based on elimination ki-

13.
netics data
14. Calculation of renal clearance
4.6 CLINICAL TOXICOLOGY(THEORY)
1. Scope and Objectives: This course is designed to impart a thorough

knowledge in the management of various poisoning cases thereby enabling
the students to assist healthcare professionals / toxicologists in handling
and managing the emergencycases.
• Understand and deal with general principles involved in the management
ofpoisoning
• Recognize the clinical symptoms and manage poisoningcases
• Educate public and healthcare professionals in the management of emer-
gencycases
83
• Minimize/ prevent the poisoning cases in localpopulation
2. Course materials ReferenceBooks:

• Matthew J Ellenhorn. Ellenhorns Medical Toxicology – Diagnosis and Treat-
ment of Poisoning. Second edition. Williams and Willkins publication,Lon-
don
• Modernmedicaltoxicology, Author V.V.Pillay, Publisher: JPBrothers
• Pediatric toxicology diagnosis and management of the poisoned child,
Timothy B, Erickson, William R. Athrens, Steven.E. AK, Cart K.Baun,Louis
J.Ling. Mcgraw-Hill; 2005.
• Lindsay Murray, Frank Dary, Mark little, Mikes Cadogan, editors. Toxicology
handbook. Australia: Churchil Livingstone, Elsevier;2007
Topic Hrs
1 General principles involved in the management of poisoning 02
2 Antidotes and the clinical applications 01
3 Supportive care in clinical Toxicology 02
4 Gut Decontamination 02
5 Elimination Enhancement 01
6 Toxicokinetics. 02
7 Clinical symptoms and management of acute poisoning with
the
following agents
a) Pesticide poisoning: organophosphorous compounds, carba- 05
mates,
organochlorines, pyrethroids
b) Opiates overdose. 01
c) Antidepressants 03
d) Barbiturates and benzodiazepines 04
e) Alcohol: ethanol, methanol 02
f) Paracetamol and salicylates 02
g) Non-steroidal anti-inflammatory drugs 02
h) Hydrocarbons: Petroleum products and PEG. 01
i) Caustics: inorganic acids and alkali 01
j) Radiation poisoning
Clinical symptoms and management of chronic poisoning
8 with the following agents - Heavy metals: Arsenic, lead, 05
mercury, iron, copper
Venomous snake bites: Families of venomous snakes, clin-
9 ical effects of venoms, general management as first aid, 02
early manifestations, complications and snakebite injuries
10 Plants poisoning. Mushrooms, Mycotoxins 02
11 Food poisonings 01
12 Envenomations – Arthropod bites and stings 01
84
Substance abuse:
13 Signs and symptoms of substance abuse and treatment of
dependence
a) CNS stimulants : Amphetamine 01
b) Opioids 01
c) CNS depressants 02
d) Hallucinogens: LSD 01
e) Cannabis group 02
f) Tobacco 01
4.7 PHARMACOTHERAPEUTICS I &II


• The pathophysiology of selected disease states and the rationale for
drugtherapy.
• The therapeutic approach to management of thesediseases.
• The controversies in drugtherapy.
• The importance of preparation of individualized therapeutic plans based
ondiagnosis.
clinical and laboratory indices of therapeutic response and adverseeffects).
rationale for drug therapy.
• Summarise the therapeutic approach to management of these diseases
including reference to the latest availableevidence.
• Discuss the controversies in drugtherapy.
• Discuss the preparation of individualized therapeutic plans based ondiag-
nosis.
laboratory indices of therapeutic response and adverseeffects).
2. Coursematerials
TEXTBOOKS
• Clinical Pharmacy and Therapeutics – Walker and Whittlesea, Churchill
Livingstone publication.
Appleton & Lange.
REFERENCE BOOKS
• Pathologic basis of disease - Robins SL, W.B.Saunderspublication.
85
• Pathology and therapeutics for Pharmacists: A Basis for Clinical Pharmacy
Practice - Green and Harris, Chapman and Hallpublication.
Wilkins Publication.
• Applied Therapeutics: The clinical Use of Drugs. Lloyd Young and Ko-
da-KimbleMA.
• Avery’s Drug Treatment, 4th Edn, 1997, Adis InternationalLimited.
Topic Hrs
Cardiovascularsystem Hypertension, Congestive cardiac failure,
1. Angina Pectoris, Myocardial infarction,,Hyperlipidemia, Electro- 13
physiology ofheart and Arrhythmias.
Respiratory system
2 Introduction to Pulmonary function test, Asthma, Chronic obstruc- 06
tive airways disease, Drug induced pulmonary diseases.
Endocrine system
3 Diabetes, Thyroid diseases, Oral contraceptives, Hormone replace- 08
ment therapy, Osteoporosis
General prescribing guidelines for
Paediatric patients
4 04
Geriatric patients
Pregnancy and breast feeding
5 Ophthalmology: Glaucoma, Conjunctivitis- viral & bacterial. 03
Introduction to rational drug use
6 Definition, Role of pharmacist Essential drug concept Rational drug 02
formulations.
Infectious disease: Guidelines for the rational use of antibiotics
and surgical Prophylaxis, Tuberculosis, Meningitis, Respiratory tract
7 infections, Gastroenteritis, Endocarditis, Septicemia, Urinary tract 18
infections, Protozoal infection- Malaria, HIV & Opportunistic infec-
tions, Fungal infections, Viral infections, Gonarrhoea and Syphillis.
Renal system
9 Acute Renal Failure, Chronic Renal Failure, Renal Dialysis, Drug 05
induced renal disorders.
Oncology: Basic principles of Cancer therapy, General introduction
10 to cancer chemotherapeutic agents, Chemotherapy of breast can- 06
cer, leukemia. Management of chemotherapy nausea and emesis.
11 Dermatology: Psoriasis, Scabies, Eczema, Impetigo. 04
86
4.7 PHARMACOTHERAPEUTICS I & II (PRACTICAL)
Hospital postings in various departments designed to complement the lectures
by providing practical clinical discussion; attending ward rounds; follow up the
progress and changes made in drug therapy in allotted patients; case presentation
upon discharge. Students are required to maintain a record of cases presented and
the same should be submitted at the end of the course for evaluation. A minimum
of 15 cases should be presented and recorded covering most commondiseases.
ASSIGNMENTS
ted forevaluation.
Assignments
- Minimum & Maximum number of pages - It shall be computer draft copy
end.
tation at the end of the academic year may be 8+2 Min

Sessionals Annual
Synopsis 05 15
Viva 02 15
Max Marks 20 70
*Total sessional marks is 30 (20 for practical sessional plus 10 marks for
regularity, promptness, viva-voce and recordmaintenance)
Pharm. D. - Fifth Year
No. of
No. of No. of
Sl. hours of
Name of Subject hours of hours of
No. Hospital
Theory Seminar
posting*
(1) (2) (3) (4) (5)
5.1 Clinical Research 3 - 1
Pharmacoepidemiology and
5.2 3 - 1
Pharmacoeconomics
Clinical Pharmacokinetics &
5.3 Pharmacotherapeutic Drug Monitor- 2 - 1
ing
87
5.4 Clerkship * - - 1
5.5 Project work (Six Months) - 20 -
* Attending ward rounds on daily basis.
5.1 CLINICAL RESEARCH(THEORY)
1. Scope and Objectives: This course is designed to make the students to

understand the principles and gain adequate knowledge regarding the var-
ious approaches to drug discovery including clinical phase of development.
Also enables the students to understand and implement all regulatory and
ethical requirements that are required during the process of drug develop-
ment.
At completion of this course, it is expected that students will be able to:

• Know the concept of new drug developmentprocess.
• Understand the regulatory and ethicalrequirements.
• Conduct the clinical trials in accordance to regulatory and ethicalrequire-
ments.
• Coordinate the clinical trials and promote quality drug trialresearch.
2. Coursematerial
TextBooks:
• Principlesandpracticeofpharmaceuticalmedicine,Secondedition.Authors:Li-
onel.D. Edward,Aadrew.J.Flether Anthony W Fos , Peter D SloaierPublish-
er:Wiley;
• Handbook of clinical research. Julia Lloyd and Ann Raven Ed. ChurchillLiv-
ingstone
• Principles of Clinical Research edited by Giovanna di Ignazio, DiGiovanna
and Haynes.
References :
• Central Drugs Standard Control Organization. Good Clinical Practic-
es-Guidelines for Clinical Trials on Pharmaceutical Products in India. New
Delhi: Ministry of Health; 2001.
• International Conference on Harmonisation of Technical requirements for
registration of Pharmaceuticals for human use. ICH Harmonised Tripartite
Guideline. Guideline for Good Clinical Practice.E6; May1996.
• Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indi-
an Council of Medical Research, NewDelhi.
• Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan
Green, March 2005, John Wiley andSons.
• Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna
and Haynes.
• Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs.
Second Edition, Jan 2000, Wiley Publications.
• Goodman & Gilman: JG Hardman, LE Limbard, 10th Edn. McGraw Hill Pub-
lications, 2001.
88
Topics Hrs
1. Drug development process:
Introduction
Various Approaches to drug discovery
1. Pharmacological
1 06
2. Toxicological
3. INDApplication
4. Drugcharacterization
5. Dosage form
2. Clinical development of drug:
1. Introduction to Clinical trials. 02
2. Various phases of clinical trial. 04
3. Methods of post marketing surveillance. 02
4. Abbreviated New Drug Application submission. 02
5. Good Clinical Practice – ICH, GCP, Central drug standard control
06
organisation (CDSCO) guidelines.
6. Challenges in the implementation of guidelines. 02
7. Ethical guidelines in Clinical Research. 01
8. Composition, responsibilities, procedures of IRB / IEC. 01
9. Overview of regulatory environment in USA, Europe and India. 08
10. Role and responsibilities of clinical trial personnel as per ICH-
GCP
a. Sponsor
b. Investigators
05
c. Clinical researchassociate
d. Auditors
e. Contract researchcoordinators
f. Regulatoryauthority
11. Designing of clinical study documents (protocol, CRF, ICF, PIC
04
with assignment).
12. Informed consent Process. 01
13. Data management and its components. 03
14. Safety monitoring in clinical trials. 03
89
5.2 PHARMACOEPIDEMIOLOGY AND PHARMACOECONOMICS
Theory : 3 Hrs./Week
1. Scope and Objectives: This course is designed to impart knowledge

regarding various methods and applications of pharmacoepidemiology and
pharmacoeconomics in drug safety monitoring, drug approval andregula-
tions.
Upon completion of this courset, it is expected that students will be able to -

• Understand drugs use pattern and their outcomemeasures
• Conduct pharmacoepidemiologicalstudies
• Adopt the tools effectively in evaluating risk and benefit oftherapy
• Conduct pharmacoeconomic studies and evaluate the cost-benefitratio
2. Course Materials:
Reference Books
• Pharmacoeconomics and outcomes: Applications for patient care, case
studies. Authors:Graer DW,Lee J,OdomTD,et al. American college of clini-
calpharmacy-2003.
• Introduction to Applied Pharmacoeconomics, F. Randy Vogenberg, New
York; London:McGraw-Hill,
• Pharmacoepidemiology Editor Brian L Storm, John Wiley and Sons, Ltd 4th
edition, 2 copies
• Clinical epidemiology- How to do clinical Practice Research. 3rd edition,
Brian Haynes, David L Sachett,Lippinkot
3. Lecturewise programme:
Topic Hrs
Pharmacoepidemiology :
Definition and scope:
1 06
Origin and evaluation of Pharmacoepidemiology, need for pharmaco-
epidemiology, aims and applications of Pharmacoepidemiology.
Measurement of outcomes in pharmacoepidemiology
Outcome measure and drug use measures
2 Prevalence, incidence and incidence rate. Monetary units, number 06
of prescriptions, units of drugs dispensed, defined daily doses and
prescribed daily doses, medication adherence measurement
Concept of risk in pharmacoepidemiology
3 Measurement of risk, attributable risk, relative risk, time-risk rela- 06
tionship and odds ratio
Pharmacoepidemiological methods
Includes theoretical aspects of various methods and practical study
of various methods with the help of case studies for individual meth-
ods;
4 Drug utilization review, case reports, case series, surveys of drug 22
use, cross – sectional studies, cohort studies, case control studies,
case –cohort studies, meta – analysis studies,
spontaneous reporting, prescription event monitoring and record
linkage system.
90
Sources of data for pharmacoepidemiological studies
5 04
Ad Hoc data sources and automated data systems.
Selected special applications of pharmacoepidemiology
6 Studies of vaccine safety, hospital pharmacoepidemiology, pharmaco- 08
epidemiology and risk management and drug induced birth defects.
7 Phrmacoeconomics:
Definition, history, needs of pharmacoeconomic evaluations 02
Role in formulary management decisions 02
Pharmacoeconomic evaluation
Outcome assessment and types of evaluation
Includes theoretical aspects of various methods and practical study of
16
various methods with the help of case studies for individual methods:
Cost – minimization, cost- benefit, cost – effectiveness and cost utili-
ty
Applications of Pharmacoeconomics 03
Software and case studies (assignment discussion) 02
5. 3 CLINICAL PHARMACOKINETICS AND THERAPEUTIC DRUG

MONITORING
Theory : 3 Hrs./Week
1. Scope and Objectives: This course is designed to make the students to

understand and apply pharmacokinetic principles in designing / individu-
alizing dosage regimen. Also, enable the students to interpret the plasma
drug range, and hepatic / renal function in optimizing the drug therapy.
On completion of the course, the student shall be able to

• Design the drug therapy regimen for individualpatient
• Interpret and correlate the plasma drug concentration with patient’sthera-
peutic outcome.
• Recommend dosage adjustment for patients with renal/ hepaticimpairment
• Detect and manage drug –druginteractions
Reference Books
• Applied Pharmacokinetics & Pharmacodynamics: Principles of Thera-
peutic Drug Monitoring;Author:MichaelE.Burton,LeslieM.Shaw,JeromeJ.
Schentag,WilliamE. Evans Published by: Lippincott Williams & Wilkins,
2005
• Handbook of Analytical Therapeutic Drug Monitoring and Toxicology By
Steven How-Yan Wong, Irving Sunshine, Published by CRC Press,1996
• Clinical pharmacokinetics, Author: Soraya Dhillon, Andrzej Kostrzewski,-
Publisher: Pharmaceutical Press
• Clinical Pharmacokinetics - Rowland and Tozer, Williams and WilkinsPubli-
cation.
• Biopharmaceutics and Applied Pharmacokinetics - Leon Shargel , Prentice
Hallpublication
91
Topics Hrs
1 Introduction to Clinical pharmacokinetics. 01
Design of dosage regimens
Nomograms and Tabulations in designing dosage regimen, conver-
2 sion from 07
intravenous to oral dosing, determination of dose and dosing inter-
vals, drug dosing in the elderly and pediatrics and obese patients.
Pharmacokinetics of DrugInteraction:
a. Pharmacokinetic druginteractions
3 03
b. Inhibition and Induction of Drugmetabolism
c. Inhibition of BiliaryExcretion.
Therapeutic Drug monitoring:
a. Introduction
b. Individualization of drug dosage regimen (Variability – Genetic,
age, weight, disease and Interactingdrugs).
4 c. Indications for TDM, Protocol forTDM. 20
d. Pharmacokinetic/Pharmacodynamic Correlation in drugtherapy.
e. TDM of drugs used in the following conditions: Cardiovascular
disease, Seizure disorders, Psychiatric conditions, and Organtrans-
plantations.
Dosage adjustment in Renal and hepatic Disease.
a. Renalimpairment
b. Pharmacokinetic considerations
c. General approach for dosage adjustment in Renaldisease.
5 10
d. Measurement of Glomerular Filtrationrate.
e. Dosage adjustment for uremicpatients.
f. Extracorporeal removal ofdrugs.
g. Effect of Hepatic disease onpharmacokinetics.
Population Pharmacokinetics.
a. Introduction to BayesianTheory.
6 05
b. Adaptive method or Dosing with feedback.
c. Analysis of Population pharmacokineticData.
7 Pharmacogenetics 04
a. Genetic polymorphism in Drug metabolism: Cytochrome P-450
Isoenzymes.
b. Genetic Polymorphism in Drug Transport and Drug Targets.
c. Pharmacogenetics and Pharmacokinetics /Pharmacodynamic con-
siderations
92
93

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1

Minimum Qualification for admission to the course

2. Pharm.D. (Post Baccalaureate)

Duration of the course

Medium of Instruction and Examinations

Working days in the academic year

Attendance and Progress

Table-1 First Year

Table-2 Second Year

Table-3 Third Year

Table-4 Fourth Year

4.7 Pharmacotherapeutics I & II* 3 3 1

Internal Assessment Marks:

Conditions under which candidates are permitted to appear for Deemed

Deemed to be University Examinations

Table-10 Fifth Year Examination

* Clerkship examination – Oral examination shall be conducted after the comple-

Criteria for pass

Conditions under which candidates are permitted to proceed to next high-

4. Methodology.― To complete the project work following methodology shall

• Final evaluation of project work shall be done on the following items:

Explanation.― For the purposes of differentiation in the evaluation in case of topic

Pharm. D. - First Year

1.1 HUMAN ANATOMY & PHYSIOLOGY (THEORY)

Theory: 3 Hrs. /Week

1. Scope and Objectives: This course is designed to impart a fundamental

Upon completion of the course the student shall be able to:

1.1 HUMAN ANATOMY & PHYSIOLOGY(PRACTICAL)

General Requirements: Laboratory napkin, muslin cloth, record, observation

Scheme of Practical Examination:

Theory : 2 Hrs. /Week

1. Scope and objectives: This course is designed to impart a fundamental

Scheme of Practical Examination:

1.3 MEDICINAL BIOCHEMISTRY(THEORY)

Theory: 3 Hrs. /Week

Upon completion of the course student shall be able to –

Reference books (Theory)

3. Lecture wise programme:

Lipid metabolism: β-Oxidation of saturated fatty acid; Ketogenesis

Liver function tests: Physiological role of liver, metabolic, storage,

Lipid profile tests: Lipoproteins, composition, functions. Determi-

1.3 MEDICINAL BIOCHEMISTRY(PRACTICAL)

Title of the Experiment:

Scheme of Practical Examination:

1.4 PHARMACEUTICAL ORGANIC CHEMISTRY(THEORY)

At the end of the course the student should be able to

3. Lecture wise programme:

Classification and Nomenclature

c. Comparison of alkyl nucleophylic substitution with

1.4 PHARMACEUTICAL ORGANIC CHEMISTRY(PRACTICAL)

Systematic qualitative analysis of unknown organic com-

Scheme of Practical Examination:

1. Scope and objectives: This course mainly deals with fundamentals of

3. Lecture wise programme:

Principles of precipitation titrations: Different methods-Mohr’s,

1.5 PHARMACEUTICAL INORGANIC CHEMISTRY(PRACTICAL)

3. Lecture wise programme:

Scheme of Practical Examination:

Pharm.D.- Second Year