Jntua 17 Regulation
Jntua 17 Regulation
Jntua 17 Regulation
in
PHARM D
AND
PHARM D(POSTBACCALAUREATE)
2. A student will be declared eligible for the award of the Pharm. D (Post Baccalaureate).
Degree if he fulfils the following academic regulations:
a)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) full time with each academic year
spread over a period of not less than two hundred working days. 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 involving posting in
speciality units. It is a phase of training wherein a student is exposed to actual pharmacy practice
or clinical pharmacy services, and acquires skill under supervision so that he or she may become
capable of functioning independently.
b) Pursue the course of study for not less than THREEacademic years and is not more than SIX
years.
c) Students, who fail to fulfil all the academic requirements for the award of the degree within
SIX academic years from the year of their admission, shall forfeit their seat in Pharm D (PB)
course and their admission is cancelled.
4. Courseof study. –
The course of study for Pharm.D. shall include the subjects as given in the Tables below. 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.
COURSE STRUCTURE
First Year:
S.No. Subjects Name of Subject No. of No. of No. of Lab S.No. Subjects
Codes hours of hours of hours of codes
Theory Tutorial Practical
Second Year:
S.No Subjects Name of Subject No. of No. of No. of Lab S.No Subjects
Codes hours of hours of hours of Codes
Theory Tutorial Practical
(1) (2) (3) (4) (5) (6) (7) (8)
Total Hours 17 6 = 32 9
Third Year:
S.N Subjects Name of Subject No. of No. of No. of Lab S.No Subjects
O Codes hours of hours of hours of Codes
Theory Tutorial Practical
(1) (2) (3) (4) (5) (6) (7) (8)
Total hours 16 5 = 36 15
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Fourth Year:
S.N Subjects Name of Subject No. of No. of No. of Lab S.No Subjects
o. Codes hours of hours of hours of Codes
Theory Tutorial Practical/
Hospital
Posting
(1) (2) (3) (4) (5) (6) (7) (8)
Fifth Year:
5.4 Clerkship* - 1 -
5.5 Project work (Six Months) - - 20
Total hours 8 4 = 32 20
* Attending ward rounds on daily basis.
Sixth Year:
Internship or residency training including postings in speciality units. Student should
independently provide the clinical pharmacy services to the allotted wards.
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5. Syllabus. – The syllabus for each subject of study in the said Tables shall be as
specified in Appendix -A to these regulations.
6. Examination. –
(1) Every year there shall be an examination to examine the students.
(2) Each examination may be held twice every year. The first examination in a year
shall be the annual examination and the second examination shall be supplementary
examination.
(3) The examinations shall be of written and practical (including oral nature) carrying
maximum marks for each part of a subject as indicated in Table below:
TABLES
First Year examination:
S.No Name of Subject Maximum marks for Theory Maximum marks for Practicals
Examin Sessional Total Examination Sessional Total
ation
1.1 Human Anatomy and 70 30 100 70 30 100
Physiology
1.2 Pharmaceutics 70 30 100 70 30 100
1.3 Medicinal Biochemistry 70 30 100 70 30 100
1.4 70 30 100 70 30 100
Pharmaceutical Organic
Chemistry
1.5 70 30 100 70 30 100
Pharmaceutical Inorganic
Chemistry
1.6 Remedial Mathematics/ 70 30 100 70 30 100
Biology
600 600 =
1200
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8. Mode of examinations
(1) Theory examination shall be of three hours and practical examination shall be of
four hours duration.
(2) A Student who fails in theory or practical examination of a subject shall re-appear
both in theory and practical of the same subject.
(3) Practical examination shall also consist of a viva –voce (Oral) examination.
(4) Clerkship examination – Oral examination shall be conducted after the completion
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,
pharmaceutical care planning and knowledge of therapeutics shall be assessed.
10. Minimum marks for passing examination.― A student shall not be declared to
have passed examination unless he or she secures at least 50% marks in each of the
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subjects separately in the theory examinations, including sessional marks and at least
50% marks in each of the practical examinations including sessional marks. The
students securing 60% marks or above in aggregate in all subjects in a single attempt
at the Pharm.D. or as the case may be, Pharm. D. (Post Baccalaureate) course
examination shall be declared to have passed in first class. Students securing 75%
marks or above in any subject or subjects shall be declared to have passed with
distinction in the subject or those subjects provided he or she passes in all the subjects
in a single attempt.
11. Eligibility for promotion to next year.- All students who have appeared for all the
subjects and passed the first year annual examination are eligible for promotion to the
second year and, so on. However, failure in more than two subjects shall debar him or
her from promotion to the next year classes.
12. Internship.―
(1) Internship is a phase of training wherein a student is expected to conduct actual
practice of pharmacy and health care and acquires skills under the supervision so that
he or she may become capable of functioning independently.
(2)Every student has to undergo one year internship as per PCI norms for Pharm D
(Appendix B).
13. Certificate of passing examination.― Every student who has passed the
examinations for the Pharm.D. (Doctor of Pharmacy) or Pharm.D. (Post
Baccalaureate) (Doctor of Pharmacy) as the case may be, shall be granted a certificate
by the examining authority.
14. 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. Each student 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 the afternoon.
15. Project work.―
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(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. 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 project work.
(2)Project work shall comprise of objectives of the work, methodology, results,
discussions and conclusions.
16. Objectives of project work.― The main objectives of the project work is to―
(i)Show the evidence of having made accurate description of published work of others
and of having recorded the findings in an impartial manner; and
(ii) Develop the students in data collection, analysis and reporting and interpretation
skills.
18. Reporting.―
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(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 the Institution
(2) Project report shall be computer typed in double space using Times 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.
(3) Submission of the project report shall be done at least one month prior to the
commencement of annual or supplementary examination.
19. Evaluation.― The following methodology shall be adopted for evaluating the
project work―
(i)Project work shall be evaluated by internal and external examiners.
(ii) Students shall be evaluated in groups for four hours (i.e., about half an hour for a
group of four students).
(iii)Three seminars presented by students shall be evaluated for twenty marks each
and the average of best two shall be forwarded to the university with marks of other
subjects.
(iv)Evaluation shall be done on the following items: Marks
a) Write up of the seminar (7.5)
b) Presentation of work (7.5)
c) Communication skills (7.5)
d) Question and answer skills (7.5)
Total (30 marks)
(v)Final evaluation of project work shall be done on the following items: Marks
a) Write up of the seminar (17.5)
b) Presentation of work (17.5)
c) Communication skills (17.5)
d) Question and answer skills (17.5)
Total (70 marks)
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 mentioned above.
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INTERNSHIP
1. SPECIFIC OBJECTIVES :
ii) to manage and use resources of the health care system, in cooperation with
patients, prescribers, other health care providers, and administrative and
supportive personnel, to promote health; to provide, assess, and coordinate
safe, accurate, and time-sensitive medication distribution; and to improve
therapeutic outcomes of medication use.
2. OTHER DETAILS :
ii) Where an intern is posted to district hospital for training, there shall be a
committee consisting of representatives of the college or university, and the
district hospital administration, who shall regulate the training of such trainee.
For such trainee a certificate of satisfactory completion of training shall be
obtained from the relevant administrative authorities which shall be
countersigned by the Principal or Dean of College.
iii) Every candidate shall be required, after passing the final Pharm.D. or
Pharm.D. (Post Baccalaureate) examination as the case may be to undergo
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3. ASSESSMENT OF INTERNSHIP :
i) The intern shall maintain a record of work which is to be verified and certified
by the preceptor (teacher practioner) under whom he works. Apart from
scrutiny of the record of work, assessment and evaluation of training shall be
undertaken by an objective approach using situation tests in knowledge, skills
and attitude during and at the end of the training. Based on the record of work
and date of evaluation, the Dean or Principal shall issue certificate of
satisfactory completion of training, following which the university shall award
the degree or declare him eligible for it.
Below Above
Poor Fair Average Excellent
Average Average
0 1 2 3 4 5
A Score of less than 3 in any of above items will represent unsatisfactory completion
of internship.
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APPENDIX - B
20. Internship
Specific Objectives:
(i) To provide patient care in cooperation with patients, prescribers, and other
members of an interprofessional health care team based upon sound
therapeutic principles and evidence-based data, taking into account relevant
legal, ethical, social cultural, economic, and professional issues, emerging
technologies, and evolving biomedical, pharmaceutical, social or behavioral or
administrative, and clinical sciences that may impact therapeutic outcomes.
(ii) To manage and use resources of the health care system, in cooperation with
patients, prescribers, other health care providers, and administrative and
supportive personnel, to promote health; to provide, assess, and coordinate
safe, accurate, and time-sensitive medication distribution; and to improve
therapeutic outcomes of medication use.
(iii)To promote health improvement, wellness, and disease prevention in co-
operation with patients, communities, at-risk population, and other members
of an interprofessional team of health care providers.
(iv) To demonstrate skills in monitoring of the National Health Programmes and
schemes, oriented to provide preventive and promotive health care services to
the community.
(v) To develop leadership qualities to function effectively as a member of the
health care team organised to deliver the health and family welfare services in
existing socio-economic, political and cultural environment.
(vi) To communicate effectively with patients and the community.
Other details
1) All parts of the internship shall be done, as far as possible, in institutions in
India. In case of any difficulties, the matter may be referred to the Pharmacy
Council of India to be considered on merits.
2) Where an intern is posted to district hospital for training, there shall be a
committee consisting of representatives of the college or university, and the
district hospital administration, who shall regulate the training of such trainee.
For such trainee a certificate of satisfactory completion of training shall be
obtained from the relevant administrative authorities which shall be
countersigned by the Principal or Dean of College.
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23. General:
i. The academic regulations should be read as a whole for purpose of any
interpretation.
ii. Disciplinary action for Malpractice / improper conductin examinations is
appended
iii. Where the words “he”, “him”, “his”, occur in the regulations, they include
“she”, “her”, “hers”.
iv. In the case of any doubt or ambiguity in the interpretation of the above rules,
the decision of the Vice-Chancellor is final.
v. The University may change or amend the academic regulations or syllabi at
any time and the changes or amendments shall be made applicable to all the
students on roles with effect from the dates notified by the University.
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If the candidate:
1. (a) Possesses or keeps accessible in examination Expulsion from the examination hall and
hall, any paper, note book, programmable cancellation of the performance in that
calculators, Cell phones, pager, palm subject only.
computers or any other form of material
concerned with or related to the subject of
the examination (theory or practical) in which
he is appearing but has not made use of
(material shall include any marks on the body
of the candidate which can be used as an aid
in the subject of the examination)
(b) Gives assistance or guidance or receives it Expulsion from the examination hall and
from any other candidate orally or by any cancellation of the performance in that
other body language methods or subject only of all the candidates involved.
communicates through cell phones with any In case of an outsider, he will be handed
candidate or persons in or outside the exam over to the police and a case is registered
hall in respect of any matter. against him.
2. Has copied in the examination hall from any Expulsion from the examination hall and
paper, book, programmable calculators, palm cancellation of the performance in that
computers or any other form of material subject and all other subjects the candidate
relevant to the subject of the examination has already appeared including practical
(theory or practical) in which the candidate is examinations and project work and shall not
appearing. be permitted to appear for the remaining
examinations of the subjects of that
Semester/year.
The Hall Ticket of the candidate is to be
cancelled and sent to the University.
3. Impersonates any other candidate in The candidate who has impersonated shall
connection with the examination. be expelled from examination hall. The
candidate is also debarred and forfeits the
seat. The performance of the original
candidate who has been impersonated, shall
be cancelled in all the subjects of the
examination (including practicals and project
work) already appeared and shall not be
allowed to appear for examinations of the
remaining subjects of that semester/year.
The candidate is also debarred for two
consecutive semesters from class work and
all University examinations. The
continuation of the course by the candidate
is subject to the academic regulations in
connection with forfeiture of seat. If the
imposter is an outsider, he will be handed
over to the police and a case is registered
against him.
4. Smuggles in the Answer book or additional Expulsion from the examination hall and
sheet or takes out or arranges to send out the cancellation of performance in that subject
question paper during the examination or and all the other subjects the candidate has
answer book or additional sheet, during or already appeared including practical
after the examination. examinations and project work and shall not
be permitted for the remaining examinations
of the subjects of that semester/year. The
candidate is also debarred for two
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10. Comes in a drunken condition to the Expulsion from the examination hall and
examination hall. cancellation of the performance in that
subject and all other subjects the candidate
has already appeared including practical
examinations and project work and shall not
be permitted for the remaining examinations
of the subjects of that semester/year.
11. Copying detected on the basis of internal Cancellation of the performance in that
evidence, such as, during valuation or during subject and all other subjects the candidate
special scrutiny. has appeared including practical
examinations and project work of that
semester/year examinations.
12. If any malpractice is detected which is not
covered in the above clauses 1 to 11 shall be
reported to the University for further action
to award suitable punishment.
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3. Course materials:
Text books
a. Tortora Gerard J. and Nicholas, P. Principles of anatomy and physiology Publisher
Harpercollins college New York.
b. Wilson, K.J.W. Ross and Wilson’s foundations of anatomy and physiology.
Publisher: Churchill Livingstone, Edinburg.
Reference books
2 i)Haemopoetic System
a)Composition and functions of blood
b)Haemopoesis and disorders of blood components (definition of d isorder)
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c)Blood groups
d)Clotting factors and mechanism
e)Platelets and disorders of coagulation
ii) Lymph
a)Lymph and lymphatic system, composition, formation and circulation.
b)Spleen: structure and functions, Disorders
c)Disorders of lymphatic system (definition only)
3 i) Respiratory system
a)Anatomy of respiratory organs and functions
b)Mechanism / physiology of respiration and regulation of respiration
c)Transport of respiratory gases
d)Respiratory volumes and capacities, and Definition of: Hypoxia, Asphyxia,
Dybarism, Oxygen therapy and resuscitation.
4 i) Urinary system
a)Anatomy and physiology of urinary system
b)Formation of urine
c) Renin Angiotensin system – Juxtaglomerular apparatus - acid base Balance
d) Clearance tests and micturition
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5 i)Sense organs
a)Eye
b)Ear
c)Skin
d)Tongue & Nose
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Practical : 3 Hrs./Week
General Requirements: Dissection box, Laboratory Napkin, muslin cloth, record, Observation
book(100pages), Stationary items, Blood lancet.
Course materials:
Text books
Goyal, R. K, Natvar M.P, and Shah S.A, Practical anatomy, physiology and biochemistry, 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 tissues of human body
(a) Epithelial tissue.
(b) Muscular tissue.
8. Determination of
(a) Blood Pressure.
(b) Blood group.
9. Study of various systems with the help of charts, models & specimens
(a) Skeleton system part I-axial skeleton.
(b)Skeleton system part II- appendicular skeleton.
(c)Cardiovascular system.
(d)Respiratory system.
(e)Digestive system.
(f)Urinary system.
(g)Nervous system.
(h)Special senses.
(i) Reproductive system.
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Sessionals Annual
Identification 04 10
Synopsis 04 10
Major Experiment 07 20
Minor Experiment 03 15
Viva 02 15
Max Marks 20 70
Duration 03hrs 04hrs
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity,
promptness, viva-voce and record maintenance).
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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 of pharmacy.
2. Upon the completion of the course the student s hould be able to:
a. know the formulation aspects of different dosage forms;
b.do different pharmaceutical caluculation involved in formulation;
c.formulate different types of dosage forms; and
d.appreciate the importance of good formulation for effectiveness.
3. Course materials:
Text books
a. Cooper and Gunns Dispensing for pharmacy students.
b.A text book Professional Pharmacy by N.K.Jain and S.N.Sharma.
Reference books
a. Introduction to Pharmaceutical dosage forms by Howard C. Ansel.
b. Remington’s Pharmaceutical Sciences.
c. Register of General Pharmacy by Cooper and Gunn.
d. General Pharmacy by M.L.Schroff.
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List of Experiments:
1. Syrups
a. Simple Syrup I.P
b.Syrup of Ephedrine Hcl NF
c.Syrup Vasaka IP
d.Syrup of ferrous Phosphate IP
e.Orange Syrup
2. Elixir
a. Piperizine citrate elixir BP
b.Cascara elixir BPC
c.Paracetamol elixir BPC
3. Linctus
a.Simple Linctus BPC
b.Pediatric simple Linctus BPC
4. Solutions
a.Solution of cresol with soap IP
b.Strong solution of ferric chloride BPC
c.Aqueous Iodine Solution IP
d.Strong solution of Iodine IP
e.Strong solution of ammonium acetate IP
5. Liniments
a. Liniment of turpentine IP*
b.Liniment of camphor IP
6. Suspensions*
a.Calamine lotion
b.Magnesium Hydroxide mixture BP
7. Emulsions*
a.Cod liver oil emulsion
b.Liquid paraffin emulsion
8. Powders*
a.Eutectic powder
b.Explosive powder
c.Dusting powder
d.Insufflations
9. Suppositories*
a.Boric acid suppositories
b.Chloral suppositories
10. Incompatibilities
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Sessionals Annual
Synopsis 05 15
Major Experiment 10 25
Minor Experiment 03 15
Viva 02 15
Max Marks 20 70
Duration 03hrs 04hrs
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity, promptness,
viva-voce and record maintenance).
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1. Scope of the Subject: Applied biochemistry deals with complete understanding of the molecular
level of the chemical process associated with living cells.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 of diseases
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1. Scope and objectives: This course is designed to impart a very good knowledge about
a. IUPAC/Common system of nomenclature of simple organic compounds
belonging to different classes of organic compounds;
b.Some important physical properties of organic compounds;
c. Free radical/ nucleophyllic [alkyl/ acyl/ aryl] /electrophyllic substitution, free radical/
nucleophyllic / electrophyllic addition, elimination, oxidation andreduction reactions
with mechanism, orientation of the reaction, order of reactivity, stability of compounds;
d. Some named organic reactions with mechanisms; and
e. Methods of preparation, test for purity, principle involved in the assay, important
medicinal uses of some important organic compounds.
2. Course materials:
Text books
a. T.R.Morrison and R. Boyd - Organic chemistry,
b. Bentley and Driver-Text book of Pharmaceutical chemistry
c. I.L.Finer- Organic chemistry, the fundamentals of chemistry
Reference books
a. Organic chemistry – J.M.Cram and D.J.Cram
b. Organic chemistry- Brown
c. Advanced organic chemistry- Jerry March, Wiley
d. Organic chemistry- Cram and Hammered, Pine Hendrickson
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diamine dihyrate, Vanillin, Paraldehyde, Ethylene chloride, Lactic acid, Tartaric acid,
citric acid, salicylic acid, aspirin, methyl salicylate, ethyl benzoate, benzylbenzoate,
dimethyl pthalate, sodium lauryl sulphate, saccharin sodium, mephensin.
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1. Scope and objectives: This course mainly deals with fundamentals of Analytical chemistry and
also the study of inorganic pharmaceuticals regarding their monographs and also the course
deals with basic knowledge of analysis of various pharmaceuticals.
3. Course materials:
Text books
a. A text book Inorganic medicinal chemistry by Surendra N. Pandeya
b.A. H. Beckett and J. B. Stanlake’s Practical Pharmaceutical chemistry Vol-I &Vol-II
c. Inorganic Pharmaceutical Chemistry III-Edition P.Gundu Rao
Reference books
a.Inorganic Pharmaceutical Chemistry by Anand&Chetwal
b.Pharmaceutical Inorganic chemistry by Dr.B.G.Nagavi
c.Analytical chemistry principles by John H. Kennedy d. I.P.1985 and 1996, Govt. of India,
Ministry of health
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d. Magnesium suphate
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REMEDIAL MATHEMATICS :
1. Scope and objectives: This is an introductory course in mathematics. This subjects deals
with the introduction to matrices, determinants, trigonometry, analytical geometry,
differential calculus, integral calculus, differential equations, laplace transform.
3. Course materials:
Text books
a. Differential calculus By Shantinarayan
b. Text book of Mathematics for second year pre- university by Prof.B.M.Sreenivas
Reference books
a. Integral calculus By Shanthinarayan
b. Engineering mathematics By B.S.Grewal
c. Trigonometry Part-I By S.L.Loney
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2. Course materials:
Text books
a. Text book of Biology by S.B.Gokhale
b. A Text book of Biology by Dr.Thulajappa and Dr.Seetaram.
Reference books
a. A Text book of Biology by B.V.Sreenivasa Naidu
b.A Text book of Biology by Naidu and Murthy
c.Botany for Degree students By A.C.Dutta.
d.Outlines of Zoology by M.Ekambaranathaayyer and T.N.Ananthakrishnan.
e.A manual for pharmaceutical biology practical by S.B.Gokhale and C.K.Kokate.
PART-B
04 Study of Animal cell
Study animal tissues
Detailed study of frog
05 Study of Pisces, Raptiles, Aves
Genearal organization of mammals
Study of poisonous animals
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Title:
1. Introduction of biology experiments
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
8. T.S. of Senna, Cassia, Ephedra, Podophyllum.
9. Simple plant physiological experiments
10. Identification of animals
11. Detailed study of Frog
12. Computer based tutorials
Sessionals Annual
Identification 04 10
Synopsis 04 10
Major Experiment 07 20
Minor Experiment 03 15
Viva 02 15
Max Marks 20 70
Duration 03 01
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity,
promptness, viva-voce and record maintenance.
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1. Scope of the Subject: This course is designed to impart a thorough knowledge of the
relevant aspects of pathology of various conditions with reference to itspharmacological
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.
2. Objectives of the Subject : Upon completion of the subject student shall be able to –
a. describe the etiology and pathogenesis of the selected disease states;
b.name the signs and symptoms of the diseases; and
c.mention the complications of the diseases.
Text books (Theory)
a.Pathologic basis of disease by- Cotran, Kumar, Robbins
b.Text book of Pathology- Harsh Mohan
c.Text book of Pathology- Y.M. Bhinde
Reference books (Theory)
a. Clinical Pharmacy and Therapeutics; Second edition; Roger Walker; Churchill
Livingstone publication
ii) Inflammation
a) Pathogenesis of acute inflammation, Chemical mediators in inflammation,
Types of chronic inflammation
b) Repairs of wounds in the skin, factors influencing healing of wounds
2 i) Diseases of Immunity
a) Introduction to Tand B cells
b) MHC proteins or transplantation antigens
c) Immune tolerance
-Hypersensitivity
Hypersensitivity type I, II, III, IV, Biological significance, Allergy due to food,
chemicals and drugs
-Autoimmunity
Criteria for autoimmunity, Classifications of autoimmune diseases in man,
mechanism of autoimmunity, Transplantation and immunologic tolerance,
allograft rejections, transplantation antigens, mechanism of rejection of
allograft.
-Acquired immune deficiency syndrome (AIDS)
- Amylodosis
ii) Infectious diseases :
Sexually transmitted diseases (HIV, Syphilis,Gonorrhea), Urinary tract infections,
Pneumonia, Typhoid, Tuberculosis, Leprosy, Malaria Dysentery (bacterial and
amoebic ), Hepatitis- infective hepatitis.
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Assignments :
Title of the Experiment
1 Chemical Mediators of inflammation
2 Drug Hypersensitivity
3 Cigarette smoking & its ill effects
4 Biological Effects of Radiation
5 Etiology and hazards of obesity
6 Complications of diabetes
7 Diagnosis of cancer
8 Disorders of vitamins
9 Methods in Pathology- Laboratory values of clinical significance
10 Pathophysiology of Dengue Hemorrhagic Fever (DHF)
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1. Scope of the Subject: Microbiology has always been an essential component of pharmacy
curriculum. This is because of the relevance of microbiology to pharmaceutical sciences and
more specifically to pharmaceutical industry. Pharmaceutical biotechnology is the logical
extension of pharmaceutical microbiology, which is expected to change the complete drug
product scenario in the future.
This course deals with the various aspects of microorganisms, its
classification,morphology, laboratory cultivation identification and maintenance. Its also
discusses with sterilization of pharmaceutical products, equipment, media etc. The course
furtherdiscusses the immunological preparations, diseases its transmission, diagnosis, control
and immunological tests.
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fungi. Differential media, enriched media and selective media, maintenance of lab
cultures.
b) Different methods used in isolation and identification of bacteria with emphasis to
different staining techniques and biochemical reactions. Counting of bacteria -Total and
Viable counting techniques.
3 a) Detailed study of different methods of sterilization including their merits and demerits.
Sterilization methods for all pharmaceutical products. Detailed study of sterility testing of
different pharmaceutical preparations .
Brief information on Validation.
b) Disinfectants- Study of disinfectants, antiseptics, fungicidal and virucidal agents
factors affecting their activation and mechanism of action. Evaluation of
bactericidal, bacteristatic,virucidal activities, evaluation of preservatives in
pharmaceutical preparations.
4 a) Immunology- Immunity, Definition, Classification, General principles of natural
immunity, Phagocytosis, acquired immunity( active and passive ) .
Antigens, chemical nature of antigens structure and formation of Antibodies, Antigen-
Antibody reactions. Bacterial exotoxins and
endotoxins. Significance of toxoids in active immunity, Immunization programme, and
importance of booster dose.
b) Diagnostic tests : Schick’s Test, Elisa test, Western Blot test, Southern BlotPCR Widal,
QBC, Mantaux Peripheral smear. Study of malarial parasite.
5 a) Microbial culture sensitivity Testing: Interpretation of results Principles
and methods of different microbiological assays, microbiological assay of
Penicillin, Streptomycin and vitamin B2 and B12. Standardisation of vaccines and sera.
b) Study of infectious diseases: Typhoid, Tuberculosis, Malaria, Cholera, Hepatitis,
Meningitis, Syphilis &Gonorrhea and HIV.
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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 occur ring drugs its history,
sources, distribution, method of cultivation, active constituents, medicinal uses, identification
tests, preservation methods, substitutes and adulterants.
3. Course materials:
Text books
a. Pharmacognosy by G.E. Trease&W.C.Evans.
b. Pharmacognosy by C.K.Kokate,Gokhale&A.C.Purohit.
Reference books
a. Pharmacognosy by Brady &Tyler.E.
b. Pharmacognosy by T.E.Wallis.
c. Pharmacognosy by C.S. Shah &Qadery.
d. Pharmacognosy by M.A. Iyengar.
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General Requirements: Laboratory Napkin, Observation Book 150 pages Zero brush, Needle,
Blade, Match box.
List of experiments:
1 Introduction of Pharmacognosy laboratory and experiments.
2 Study of cell wall constituents and cell inclusions.
3 Macro, powder and microscopic study of Datura.
4 Macro, powder and microscopic study of Senna.
5 Macro, powder and microscopic study of Cassia. cinnamon.
6 Macro, powder and microscopic study of Cinchona.
7 Macro, powder and microscopic study of Ephedra.
8 Macro, powder and microscopic study of Quassia.
9 Macro, powder and microscopic study of Clove
10 Macro, powder and microscopic study of Fennel.
11 Macro, powder and microscopic study of Coriander.
12 Macro, powder and microscopic study of Isapgol.
13 Macro, powder and microscopic study of Nux vomica.
14 Macro, powder and microscopic study of Rauwolfia.
15 Macro, powder and microscopic study of Liquorice.
16 Macro, powder and microscopic study of Ginger.
17 Macro, powder and microscopic study of Podophyllum.
18 Determination of Iodine value.
19 Determination of Saponification value and unsaponifiable matter.
20 Determination of ester value.
21 Determination of Acid value.
22 Chemical tests for Acacia.
23 Chemical tests for Tragacanth.
24 Chemical tests for Agar.
25 Chemical tests for Starch.
26 Chemical tests for Lipids.(castor oil, sesame oil, shark liver oil, bees wax)
27 Chemical tests for Gelatin.
Scheme of Practical Examination:
Sessionals Annual
Identification 04 10
Synopsis 04 10
Major Experiment 07 20
Minor Experiment 03 15
Viva 02 15
Max Marks 20 70
Duration 03hrs 04hrs
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity,
promptness, viva- voce and record maintenance.
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1. Scope of the Subject: This subject will provide an opportunity for the student to learn
about the drug with regard to classification, pharmacodynamic 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 acting on autonomic nervous system, cardiovascular system, central nervous
system, blood and blood forming agents and renal system will be
taught. In addition to theoretical knowledge, the basic practical knowledge relevant to therapeutics
will be imparted.
2. Objectives of the Subject: Upon completion of the subject student shall be able to (Know, do,
appreciate) –
a. understand the pharmacological aspects of drugs falling under the above mentioned chapters;
b. handle and carry out the animal experiments;
c. appreciate the importance of pharmacology subject as a basis of therapeutics; and
d. correlate and apply the knowledge therapeutically.
Text books(Theory) (Author, Title, Edition, Publication Place, Publisher, Year of Publication)
a. Tripathi, K. D. Essentials of medical pharmacology. 4t h Ed, 1999. Publisher: Jaypee, Delhi.
b. Satoskar, R.S. and Bhadarkar, S.D. Pharmacology and pharmacotherapeutics. 16t h edition
(single volume), 1999. Publisher: Popular, Dubai.
c. Rang, H.P. & Dale, M.M. Pharmacology. 4t h edition, 1999. Publisher: Churchill Living
stone.
Reference books (Theory)(Author, Title, Edition, Publication Place, Publisher, Publication Year)
a. Goodman Gilman, A., Rall, T.W., Nies, A.I.S. and Taylor, P. Goodman and
Gilman’s The pharmacological Basis of therapeutics. 9t h Ed, 1996. Publisher Mc Graw Hill,
Pergamon press.
b. Craig, C.R.&Stitzel, R.E. Modern Pharmacology. Latest edition. Publisher : Little Brown.Co
c. Katzung, B.G. Basic and clinical pharmacology. Latest edition. Publisher: Prentice Hall, Int.
d. Shargel and Leon. Applied Biopharmaceutics and pharmacokinetics. Latest edition.
Publisher: Prentice Hall, London.
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d. Ian Kitchen. Textbook of in vitro practical pharmacology. Latest edition, Publisher: Black
well Scientific.
1. General Pharmacology
a) Introduction, definitions and scope of pharmacology
b) Routes of administration of drugs
c) Pharmacokinetics (absorption, distribution, metabolism and excretion)
d) Pharmacodynamics
e) Factors modifying drug effects
f) Drug toxicity - Acute, sub- acute and chronic toxicity.
g) Pre-clinical evaluations
h) Drug interactions
Note: The term Pharmacology used here refers to the classification, mechanism of action,
pharmacokinetics, pharmacodynamics, adverse effects, contraindications, Therapeutic uses,
interactions and dose and route of administration.
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1. Scope: In the changing scenario of pharmacy practice in India, Community Pharmacists are
expected to offer various pharmaceutical care services. In order to meet this demand, students
will be learning various skills such as dispensing of drugs, responding to minor ailments by
providing suitable safe medication, patient counselling, health screening services for improved
patient care in the community set up.
Text Books:
a. Health Education and Community Pharmacy by N.S.Parmar.
b. WHO consultative group report.
c. Drug store & Business management by Mohammed Ali &Jyoti.
Reference books:
a. Handbook of pharmacy – health care.Edt. Robin J Harman. The Pharmaceutical press.
b. Comprehensive Pharmacy Review – Edt. Leon Shargel. Lippincott Williams & Wilkins.
Special requirements:
1. Either the college is having model community pharmacy (meeting the schedule N
requirement) or sign MoU with at least 4-5 community pharmacies nearby to the college for
training the students on dispensing and counselling activities.
2. Special equipments like B.P apparatus, Glucometer, Peak flow meter, and apparatus for
cholesterol estimation.
3. Scheme of evaluation (80 Marks)
1. Synopsis 10
2. Major Experiment 30
(Counselling of patients with specific diseases – emphasis should be given on
Counselling introduction, content, process and conclusion)
3. Minor Experiment(Ability to measure B.P/ CBG / Lung function) 15
4. Prescription Analysis (Analyzing the prescriptions for probable drug interaction
andability to tell the management) 15
5. Viva – Voce 10
Lecture wise programme:
Topics
1 Definition, scope, of community pharmacy
Roles and responsibilities of Community pharmacist
Community Pharmacy Management
a) Selection of site, Space layout, and design
b) Staff, Materials- coding, stocking
c) Legal requirements
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1. Scope of the Subject: 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 their management.
Text Books
a. Clinical Pharmacy and Therapeutics - Roger and Walker, Churchill Livingstone
publication.
b. Pharmacotherapy: A Pathophysiologic approach - Joseph T. Dipiro et al. Appleton &
Lange.
Reference Books
a. Pathologic basis of disease - Robins SL, W.B.Saunders publication.
b. Pathology and therapeutics for Pharmacists: A Basis for Clinical Pharmacy Practice -
Green and Harris, Chapman and Hall publication.
c. Clinical Pharmacy and Therapeutics - Eric T. Herfindal, Williams and Wilkins
Publication.
d. Applied Therapeutics:The clinical Use of Drugs. Lloyd Young and Koda-Kimble MA
e. Avery’s Drug Treatment, 4th Edn, 1997, Adis International Limited.
f. Relevant review articles from recent medical and pharmaceutical literature.
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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 diseases. A minimum of THREE
assignments [1500 – 2000 words] should be submitted for evaluation.
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1. Scope of the Subject: This subject will provide an opportunity for the student to learn
about the drug with regard to classification, pharmacodynamic and pharmacokinetic aspects,
adverse effects, uses, dose, route of administration, precautions, contraindications and
interaction with other drugs. In this subject, drugs acting on autacoids, respiratorysystem, GIT,
immune system and hormones, and pharmacology of autocoids and hormones will be
concentrated. In addition, pharmacology of chemotherapeutic agents, vitamins, essential
minerals and principles of toxicology are also taught. In addition to theoretical knowledge, the
basic practical knowledge relevant to therapeutics will be imparted.
2. Objectives of the Subject Upon completion of the subject student shall be able to:
a. understand the pharmacological aspects of drugs falling under the above mentioned
chapters,
b. carry out the animal experiments confidently,
c. appreciate the importance of pharmacology subject as a basis of therapeutics, and
d. correlate and apply the knowledge therapeutically.
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2. Chemotherapy
a)Introduction
b)Sulfonamides and co-trimoxazole
c)Penicillins and Cephalosporins
d) Tetracyclins and Chloramphenicol
e)Macrolides, Aminoglycosides, Polyene& Polypeptide antibiotics
f)Quinolines and Fluroquinolines
g)Antifungal antibiotics
h)Antiviral agents
i)Chemotherapy of tuberculosis and leprosy
j)Chemotherapy of Malaria
k)Chemotherapy of protozoal infections (amoebiasis, Giardiasis)
l)Pharmacology of Anthelmintic drugs
m)Chemotherapy of cancer (Neoplasms)
4. The dynamic cell:The structures and functions of the components of the cell
a) Cell and macromolecules: Cellular classification, subcellular organelles, macromolecules,
large macromolecular assemblies
b) Chromosome structure: Pro and eukaryotic chromosomestructures, chromatin
structure, genome complexity, the flow of genetic information.
c) DNA replication: General, bacterial and eukaryotic DNA replication.
d) The cell cycle: Restriction point, cell cycle regulators and modifiers.
e) Cell signaling: Communication between cells and theirenvironment, ion-channels,
signal transduction pathways (MAP kinase, P38 kinase, JNK, Ras and PI3-kinase
pathways, biosensors.
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Books:
1 Molecular Biology of the Cell by Alberts B., Bray, D., Lewis, J., Raff M., Roberts, K and
Watson, JD, 3rd edition.
2 Molecular Cell Biology ByLodish, H., Baltimore, D., Berk, A et al., 5t h edition.
3 Molecular Biology by Turner, PC., McLennan, AG., Bates, AD and White MRH 2nd edition.
4 Genes VIII by Lewin, B., (2004)
5 Pharmaceutical Biotechnology, by Crommelin, DJA and Sindelar RD (1997)
6 Recombinant DNA by Watson, JD., Gilman, M., et al., (1996)
7 Biopharmaceutical: Biochemistry and Biotechnology by Walsh, G., (1998)
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List of Experiments:
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 experimental pharmacology.
3. Study of laboratory appliances used in experimental pharmacology.
4. Study of use of anesthetics in laboratory animals.
5. To record the dose response curve of Ach using isolated ileum/rectus abdominis muscle
preparation.
6. To carry out bioassay of Ach using isolated ileum/rectus abdominis muscle preparation by
interpolation method.
7. To carry out bioassay of Ach using isolated ileum/rectus abdominis muscle preparation by
three point method.
8. To record the dose response curve of Histamine using isolated guinea-pig ileum preparation.
9. Study of agonistic and antagonistic effects of drugs using isolated guinea-pig ileum
preparation.
10. To carry out bioassay of Histamine using isolated guinea-pig ileum preparation by
interpolation method.
11. To carry out bioassay of Histamine using guinea-pig ileum preparation by three point method.
12. To study the 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:
a) Analgesic property of drug using analgesiometer.
b) Antiinflammatory effect of drugs using rat-paw edema method.
c) Anticonvulsant activity of drugs using maximal electroshock and pentylenetetrazole methods.
d) Antidepressant activity of drugs using pole climbing apparatus and pentobarbitone induced
sleeping time methods.
e) Locomotor activity evaluation of drugs using actophotometer and rotorod.
f) Cardiotonic activity of drugs using isolated frog heart and mammalian heart preparations.
Viva 02 10
Max Marks 20 70
Duration 3hrs 4hrs
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity,
promptness, viva- voce and record maintenance).
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1. Quality Assurance:
a. Introduction, sources of quality variation, control of quality variation.
b. Concept of statistical quality control.
c. Validation methods- quality of equipment, validation of equipment and validation of
analytical instruments and calibration.
d. GLP, ISO 9000.
e. Total quality management, quality review and documentation.
f. ICH- international conference for harmonization-guidelines.
g. Regulatory control.
2. Chromatography:
Introduction, history, classification, separation techniques, choice of methods.
The following techniques be discussed with relevant examples of pharmaceutical products
involving principles and techniques of separation of drugs from excipients.
a. Column Chromatography: Adsorption column chromatography, Operational
technique, frontal analysis and elution analysis. Factors affecting column efficiency,
applications and partition chromatography.
b. TLC: Introduction, principle, techniques, Rf value and applications.
c. PC: Introduction, principle, types of paper chromatography, preparation techniques,
development techniques, applications.
d. Ion-exchange chromatography : Introduction, principles, types of ion
exchange synthetic resins, physical properties, factors affecting ion
exchange, methodology and applications.
e. HPLC: Introduction, theory, instrumentation, and applications.
f. HPTLC: Introduction, theory, instrumentation, and applications.
g. Gas Chromatography: Introduction, theory, instrumentation-carriergases, types of
columns, stationary phases in GLC & GSC. Detectors-Flame ionization detectors,
electron capture detector, thermal conductivity detector. Typical gas chromatogram,
derivatisation techniques, programmed temperature gas chromatography, applications.
h. Electrophoresis: Principles of separation, equipment for paper and gel electrophoresis,
and application.
i. Gel filtration and affinity chromatography: Introduction, technique, applications.
3. Electrometric Methods:
Theoretical aspects, instrumentation, interpretation of data/spectra and analytical applications
be discussed on the following topics.
a. Potentiometry: Electrical potential, electrochemical cell, reference electrodes, indicator
electrodes, measurement of potential and pH, construction and workingof electrodes,
Potentiometric titrations, methods of detecting e nd point, Karl Fischer titration.
b. Conductometry: Introduction, conductivity cell, conductometric titrations and
applications.
c. Polarography: Instrumentation, DME, residual current, diffusion current andlimiting
current, polarographic wave, Ilkovic’s equation, Effect of oxygen on polarographic
wave, Polarographic maxima and suppressors and applications.
d. Amperometric Titrations: Introduction, types of electrodes used, reference and
indicator electrode, instrumentation, titration procedure, advantages and disadvantages
of Amperometry over potentiometry. Pharma applications.
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4. Spectroscopy:
Theoretical aspects, instrumentation, elements of interpretation of data/spectra and application
of analytical techniques 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 of equilibrium
constant and rate constant by spectroscopy. Spectra of isolated
chromophores,auxochromes, batho-chromic shift, hypsochromic shift, hyperchromic
and hypochromic effect, effect of solvent on absorption spectra,molecular structure and
infrared spectra.
Instrumentation – Photometer, U.V.-Visible spectrophotometer –
sources of U.V.-Visible radiations, collimating systems,
monochromators, samples cells and following detectors-Photocell,Barrier layer cell,
Phototube, Diode array, applications of U.V.-Visible spectroscopy in pharmacy and
spectrophotometric titrations.
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List of Experiments:
1. Separation and identification of Amino Acids by Paper Chromatography.
2. Separation and identification of Sulpha drugs by TLC technique.
3. Effect of pH and solvent on the UV spectrum of given compound.
4. Comparison of the UV spectrum of a compound with that of its derivatives.
5. Determination of dissociation constant of indicators using UV-Visible spectroscopy.
6. Conductometric titration of mixture of acids with a strong base.
7. Potentiometric titration of aacid with a strong base.
8. Estimation of drugs by Fluorimetric technique.
9. Study of quenching effect in fluorimetry.
10. Colourimetric estimation of Supha drugs using BMR reagent.
11. Simultaneous estimation of two drugs present in given formulation.
12.Assay of Salicylic Acid by colourimetry.
13.Determination of Chlorides and Sulphates in Calcium gluconate by Nepheloturbidimetric
Method.
14.Determination of Na/K by Flame Photometry.
15. Determination of pKa using pH meter.
16. Determination of specific rotation.
17. Comparison of the IR spectrum of a compound with that of its derivatives.
18. Demonstration of HPLC.
19. Demonstration of HPTLC.
20. Demonstration of GC-MS.
21. Demonstration of DSC.
22. Interpretation of NMR spectra of any one compound.
Reference Books:
1. Text Book of Pharm. Analysis by Higuchi. T and Hasen. E. B., New York Inter Science
Publishers.
2. Quantitative Pharma. Analysis by Jenkins, The Blakiston division, New York.
3. Quantitative Drug Analysis, by Garrot. D, Chapman & Hall Ltd., London.
4. Undergraduate Instrumental Analysis by James. E., CBS Publishers.
5. Instrumental Analysis by Willard and Merritt, EWP, East West Press Ltd.,
Delhi/Madras.
6. Pharm Analysis by Skoog and West, Sounders Manipal College Publishing.
7. Text Book of Chemical Analysis, by A.I.Vogel, ELBS with Macmillan press,
Hampshire.
8. Textbook of Pharm. Analysis by K.A.Connors, John Wiley & Sons, New York,
Brisbane, Singapore.
9. Textbook of Pharm. Analysis (Practical) by Beckett &Stenlake, CBS
Publishers, Delhi.
10. Textbook of Drug Analysis by P.D. Sethi., CBS Publishers, Delhi.
11. Spectroscopy by Silverstein, John & Wiley & Sons. Inc., Canada & Singapore.
12. How to practise GMP-A Plan for total quality control by P.P. Sharma,
VandanaPublications, Agra.
13. The Science & Practice of Pharmacy by Remington Vol-I & II, Mack Publishing Co.
Pennsylvania.
14. TLC by Stahl, Spring Verlay.
15. Text Book of Pharm. Chemistry by Chatten, CBS Publications.
16. Spectroscopy by William Kemp, ELBS with Macmillan Press, Hampshire.
17. I.P.-1996, The Controller of Publications, New Delhi.
18. BPC- Dept. of Health, U.K. for HMSO.
19. USP - Mack Publishing Co., Easton, PA.
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Practicals
Title of the Experiment:
1 Study of agonistic and antagonistic effects of drugs using Guinea-pig ileum preparation.**
2 To study the effects of drugs on intestinal motility using frog’s esophagus model*
3 To study the effects of drugs using rat uterus preparation.**
4 To study the anticonvulsant property of drugs (any one model).*
5 To study antihistaminic property of drug using histamine induced anaphylactic reaction in
guinea pigs.
6 To study the apomorphine- induced compulsive behaviour (stereotypy) in mice.*
7 To study the muscle relaxant property of diazepam in mice using rotarod apparatus.*
8 To study the antiinflammatory property of indomethacin against carrageenan- induced paw
oedema.**
9 To study the anxiolytic effect of diazepam in mice using mirrored-chamber apparatus.**
10 To demonstrate the effect of various drugs on the blood pressure and respiration of
anaesthetized dog.
11 To study the effect of anthelmintics on earthworms.
12 To study the taming effect of chlorpromazine.*
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity,
promptness, viva- voce and record maintenance).
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1. Scope of the Subject: This course is designed to impart knowledge and skills necessary for
contribution to quality use of medicines. Chapters dealt cover briefly pathophysiologyand
mostly therapeutics of various diseases. This will enable the student to understand the
pathophysiology of common diseases and their management.
2. Objectives of the Subject Upon completion of the subject student shall be able to –
a. know the pathophysiology of selected disease states and the rationale for drug therapy
b. know the therapeutic approach to management of these diseases;
c. know the controversies in drug therapy;
d. know the importance of preparation of individualised therapeutic plans based on
diagnosis; and
e. appreciate the needs to 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 adverse effects).
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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 diseases. A minimum of THREE
assignments [1500 – 2000 words] should be submitted for evaluation.
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1. Scope of the Subject: (4-6 lines): 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 are the core of this course. Other acts, which are covered, include
the Pharmacy Act, dangerous drugs, medicinal and toilet preparation Act etc. Besides this the
new drug policy, professional ethics, DPCO, patent and design Act will be discussed.
2. Objectives of the Subject: Upon completion of the subject student shall be able to (Know,
do, and appreciate) –
a. practice the Professional ethics;
b. understand the various concepts of the pharmaceutical legislation in India;
c. know the various parameters in the Drug and Cosmetic Act and rules ;
d. know the Drug policy, DPCO, Patent and design act;
e. understand the labeling requirements and packaging guidelines for drugs and cosmetics;
f. be able to understand the concepts of Dangerous Drugs Act, Pharmacy Act and Excise
duties Act; and
g. other laws as prescribed by the Pharmacy Council of India from time to time including
International Laws.
Text books (Theory)
Mithal , B M. Textbook of Forensic Pharmacy. Calcutta:National; 1988.
Reference books (Theory)
a. Singh, KK, editor. Beotra’s the Laws of Drugs, Medicines & cosmetics. Allahabad: Law
Book House; 1984.
b. Jain, NK. A Textbook of forensic pharmacy. Delhi: Vallabhprakashan ; 1995.
c. Reports of the Pharmaceutical enquiry Committee
d. I.D.M.A., Mumbai. DPCO 1995
e. Various reports of Amendments.
f. Deshapande, S.W. The drugs and magic remedies act 1954 and rules 1955. Mumbai:
Susmit Publications; 1998.
g. Eastern Book Company .The narcotic and psychotropic substances act 1985, Lucknow:
Eastern; 1987.
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Constitution and Functions of DTAB,DCC,CDL. Qualification and duties –Govt. analyst and
Drugs Inspector.
3. Pharmacy Act –1948.
Objectives Legal Definitions, General Study, Constitution and Functions of State & Central
Council, Registration & Procedure, ER.
Medicinal and Toilet Preparation Act –1955.
Objectives, Legal Definitions, Licensing, Bonded and Non Bonded Laboratory, Ware
Housing, Manufacture of Ayurvedic, Homeopathic, Patent &Proprietory Preparations.
4. Narcotic Drugs and Psychotropic substances Act-1985 and Rules. Objectives, Legal
Definitions, General Study, Constitution and Functions of narcotic & Psychotropic
Consultative Committee, National Fund for Controlling the Drug Abuse, Prohibition, Control
and regulations, Schedules to the Act.
Study of Salient Features of Drugs and magic remedies Act and its rules.
Study of essential Commodities Act Relevant to drugs price control Order.
5. Drug Price control Order & National Drug Policy (Current).
Prevention Of Cruelty to animals Act-1960.
Patents & design Act-1970.
Brief study of prescription and Non-prescription Products.
4. Assignments:
Format of the assignment
1. Minimum & Maximum number of pages
2. It shall be a computer draft copy
3. Reference(s) shall be included at the end.
4. Name and signature of the student
5. Assignment can be a combined presentation at the end of the academic year.
6. Time allocated for presentation may be 8+2 Min
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5. Hypoglycemic agents
Thyroid and Antithyroid agents
Diureties
Diagnostic agents
Steroidal Hormones and Adrenocorticoids
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Practical :3 Hrs./Week
Reference Books:
a. Wilson and Gisvold’s Text book of Organic, Medicinal and Pharmaceutical
Chemistry, Lippincott-Raven Publishers-New York, Philadelphia.
b. William.O.Foye, Principles of Medicinal Chemistry, B.I. Waverly Pvt. Ltd., New
Delhi.
c. Burgers, Medicinal Chemistry, M.E.,WellyMed.Chemistry M.E. WalffedJohnwilley
and Sons, Wiley-interscience Publication, New York, Toranto.
d. A Text Book of Medicinal Chemistry Vol. I and II by Surendra N. Pandeya, S.G.
Publisher, 6, Dildayal Nagar, Varanasi -10.
e. Indian Pharmacopoeia 1985 and 1996. The Controller of Publications, Civil Lines,
Delhi - 54.
f. Current Index of Medical Specialities (CIMS) and MIMS India, MIMS, A.E. Morgan
Publications (I) Pvt. Ltd, New Delhi-19.
g. Organic Drug Synthesis-LedniserMitzsher Vol. I and II.
h. Pharmaceutical Chemistry drug Synthesis Vol. I and II by H. J. Roth and A.
Kleemann.
i. The Science and Practice of Pharmacy Vol. 1 and 2, Remington, MACK Publishing
company, Easton, Pennsylvania.
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1. Scope of the Subject: Scope and objectives of the course: Subject deals with the formulation and
evaluation of various pharmaceutical dosage forms.
2. Objectives of the Subject: Upon completion of the subject student shall be able to (Know, do,
appreciate) –
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Practical : 3 Hrs./Week
List of Experiments:
1. Manufacture of Tablets
a. Ordinary compressed tablet-wet granulation
b. Tablets prepared by direct compression.
c. Soluble tablet.
d. Chewable tablet.
2. Formulation and filling of hard gelatin capsules
3. Manufacture of parenterals
a. Ascorbic acid injection
b. Calcium gluconate injection
c. Sodium chloride infusion.
d. Dextrose and Sodium chloride injection/ infusion.
4. Evaluation of Pharmaceutical formulations (QC tests)
a. Tablets
b. Capsules
c. Injections
5. Formulation of two liquid oral preparations and evaluation by assay
a. Solution: Paracetamol Syrup
b. Antacid suspensions- Aluminum hydroxide gel
6. Formulation of semisolids and evaluation by assay
a. Salicyclic acid and benzoic acid ointment
b. Gel formulation Diclofenac gel
7. Cosmetic preparations
a. Lipsticks
b. Cold cream and vanishing cream
c. Clear liquid shampoo
d. Tooth paste and tooth powders.
8. Tablet coating (demonstration)
Scheme of Practical Examination :
Sessionals Annual
Synopsis 05 15
Major Experiment 10 25
Minor Experiment 03 15
Viva 02 15
Max Marks 20 70
Duration 03hrs 04hrs
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity,
promptness, viva- voce and record maintenance).
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1. Scope: 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 their management.
2. Objectives: At completion of this subject it is expected that students will be able to understand –
a. the pathophysiology of selected disease states and the rationale for drug therapy;
b. the therapeutic approach to management of these diseases;
c. the controversies in drug therapy;
d. the importance of preparation of individualised therapeutic plans based on diagnosis;
e. needs to 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 adverse effects);
f. describe the pathophysiology of selected disease states and explain the rationale for drug
therapy;
g. to summarize the therapeutic approach to management of these diseases including reference to
the latest available evidence;
h. to discuss the controversies in drug therapy;
i. to discuss the preparation of individualised therapeutic plans based on diagnosis; and
j. 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 adverse effects).
Etiopathogenesis and pharmacotherapy of diseases associated with following systems/ diseases:
Title of the topic
1 Gastrointestinal system: Peptic ulcer disease, Gastro Esophageal Reflux Disease, Inflammatory
bowel disease, Liver disorders - Alcoholic liver disease, Viral hepatitis including jaundice, and
Drug induced liver disorders.
2 Haematological system:Anaemias, Venous thromboembolism, Drug induced blood disorders.
3 Nervous system: Epilepsy, Parkinsonism, Stroke, Alzheimer's disease,
4 Psychiatry disorders: Schizophrenia, Affective disorders, Anxiety disorders, Sleep disorders,
Obsessive Compulsive disorders
5 Pain management including Pain pathways, neuralgias, and headaches.
Evidence Based Medicine
Text Books
a. Clinical Pharmacy and Therapeutics - Roger and Walker, Churchill Livingstone publication
b. Pharmacotherapy: A Pathophysiologic approach - Joseph T. Dipiro et al. Appleton & Lange
Reference Books
a. Pathologic basis of disease - Robins SL, W.B.Saunders publication
b. Pathology and therapeutics for Pharmacists: A Basis for Clinical Pharmacy Practice - Green
and Harris, Chapman and Hall publication
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c. Clinical Pharmacy and Therapeutics - Eric T. Herfindal, Williams and Wilkins Publication
d. Applied Therapeutics: The clinical Use of Drugs. Lloyd Young and Koda-Kimble
MA
e. Avery’s Drug Treatment, 4th Edn, 1997, Adis International Limited.
f. Relevant review articles from recent medical and pharmaceutical literature.
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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 diseases. A minimum of THREE
assignments [1500 – 2000 words] should be submitted for evaluation.
Max Marks 20 70
Duration 03hrs 04hrs
Note: Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity,
promptness, viva- voce and record maintenance).
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1. Scope: In the changing scenario of pharmacy practice in India, for successful practice of
Hospital Pharmacy, the students are required to learn various skills like drug distribution, drug
dispensing, manufacturing of parenteral preparations, drug information, patient counselling,
and therapeutic drug monitoring for improved patient care.
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Practical:3 Hrs./Week
List of Assignments:
1. Design and Management of Hospital pharmacy department for a 300 bedded hospital.
2. Pharmacy and Therapeutics committee – Organization, functions, and limitations.
3. Development of a hospital formulary for 300 bedded teaching hospital
4. Preparation of ABC analysis of drugs sold in one month from the pharmacy.
5. Different phases of clinical trials with elements to be evaluated.
6. Various sources of drug information and systematic approach to provide unbiased drug
information.
7. Evaluation of prescriptions generated in hospital for drug interactions and find out the suitable
management.
Special requirements:
1. Each college should sign MoU with nearby local hospital having minimum 150 beds for
providing necessary training to the students’ on hospital pharmacy activities.
Sessionals Annual
Synopsis 05 15
Major Experiment 10 25
Minor Experiment 03 15
Viva 02 15
Max Marks 20 70
Duration 03hrs 04hrs
Note : Total sessional marks is 30 (20 for practical sessional plus 10 marks for regularity,
promptness, viva- voce and record maintenance).
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References
a. Australian drug information -Procedure manual. The Society of Hospital Pharmacists of
Australia.
b. Clinical Pharmacokinetics - Rowland and Tozer, Williams and Wilkins Publication.
c. Pharmaceutical statistics. Practical and clinical applications. Sanford Bolton, Marcel
Dekker, Inc.
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The patient's case history, its structure and use in evaluation of drug therapy & Understanding
common medical abbreviations and terminologies used in clinical practices.
2. Clinical laboratory tests used in the evaluation of disease states, and interpretation of
test results
a. Haematological, Liver function, Renal function, thyroid function tests
b. Tests associated with cardiac disorders
c. Fluid and electrolyte balance
d. Microbiological culture sensitivity tests
e. Pulmonary Function Tests
4. Pharmacovigilance
a. Scope, definition and aims of pharmacovigilance
b. Adverse drug reactions - Classification, mechanism, predisposing factors, causality
assessment [different scales used]
c. Reporting, evaluation, monitoring, preventing & management of ADRs
d. Role of pharmacist in management of ADR.
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Practical:3 Hrs./Week
Students are expected to perform 15 practicals in the following areas covering the topics dealt in
theory class.
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 counselling, Critical
appraisal of recently published articles in the biomedical literature which deals with a drug or
therapeutic issue.
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2. Biostatistics
2.1 a) Introduction
b) Types of data distribution
c) Measures describing the central tendency distributions- average, median, mode
d) Measurement of the spread of data-range, variation of mean, standard deviation, variance,
coefficient of variation, standard error of mean.
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Use of Computers for Pharmaceutical Care in community pharmacy Accounting and General
ledger system
Drug Information Retrieval & Storage:
Introduction – Advantages of Computerized Literature Retrieval
Use of Computerized Retrieval
Reference books:
a. Pharmaceutical statistics- practical and clinical applications, Sanford Bolton 3rd edition,
publisher Marcel Dekker Inc. NewYork.
b. Drug Information- A Guide for Pharmacists, Patrick M Malone, Karen L Kier, John E
Stanovich , 3rd edition, McGraw Hill Publications 2006
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1. Biopharmaceutics
1. Introduction to Biopharmaceutics
a. Absorption of drugs from gastrointestinal tract.
b. Drug Distribution.
c. Drug Elimination.
2. Pharmacokinetics
2. Introduction to Pharmacokinetics.
a. Mathematical model
b. Drug levels in blood.
c. Pharmacokinetic model
d. Compartment models
e. Pharmacokinetic study.
3. One compartment open model.
a. Intravenous Injection (Bolus)
b. Intravenous infusion.
Multicompartment models.
a. Two compartment open model.
b. IV bolus, IV infusion and oral administration
4. Multiple – Dosage Regimens.
a. Repititive Intravenous injections – One Compartment Open Model
b. Repititive Extravascular dosing – One Compartment Open model
c. Multiple Dose Regimen – Two Compartment Open Model
Nonlinear Pharmacokinetics.
a. Introduction
b. Factors causing Non-linearity.
c. Michaelis- menton method of estimating parameters.
5. Noncompartmental Pharmacokinetics.
a. Statistical Moment Theory.
b. MRT for various compartment models.
c. Physiological Pharmacokinetic model.
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Practical:3 Hrs./Week
References:
a. Biopharmaceutics and C linical Pharmacokinetics by, Milo Gibaldi
b. Remington’s Pharmaceutical Sciences, By Mack Publishing Company, Pennsylvnia.
c. Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel Dekker Inc.
d. Hand Book of Clinical Pharmacokinetics, By Milo Gibaldi and Laurie Prescott by ADIS
Health Science Press.
e. Biopharmaceutics and Pharmacokinetics; By Robert F Notari
f. Biopharmaceutics; By Swarbrick
g. Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and Sunil
B.Jaiswal, VallabhPrakashanPitampura, Delhi
h. Cilincal Pharmacokinetics, Concepts and Applications: By Malcolm Rowland and
Thomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.
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References:
a. Matthew J Ellenhorn. ELLENHORNS MEDICAL TOXICOLOGY – DIAGNOSIS AND
TREATMENT OF POISONING. Second edition. Williams and Willkins publication, London
b. V VPillay. HANDBOOK OF FORENSIC MEDICINE AND TOXICOLOGY. Thirteenth
edition 2003 Paras Publication, Hyderabad
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Sessionals Annual
Synopsis 05 15
Major Experiment 10 25
Minor Experiment 03 15
Viva 02 15
Max Marks 20 70
Duration 03 hrs 04 hrs
Note: Total sessional marks is 30 (20 for practical sessional plus 10 marksfor regularity,
promptness, viva-voce and record maintenance).
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References:
a. Central Drugs Standard Control Organization. Good Clinical Practices-Guidelines for Clinical
Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health; 2001.
b. International Conference on Harmonisation of Technical requirements for registration of
Pharmaceuticals for human use. ICH Harmonised Tripartite Guideline. Guideline for Good
Clinical Practice.E6; May 1996.
c. Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian Council of
Medical Research, New Delhi.
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d. Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Green, March
2005, John Wiley and Sons.
e. Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and Haynes.
f. Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second Edition,
Jan 2000, Wiley Publications.
g. Goodman & Gilman: JG Hardman, LE Limbard, 10th Edn. McGraw Hill Publications,2001.
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1. Pharmacoepidemiology:
Definition and scope:
Origin and evaluation of pharmacoepidemiology need for pharmacoepidemiology, aims and
applications.
Measurement of outcomes in pharmacoepidemiology
Outcome measure and drug use measures
Prevalence, incidence and incidence rate. Monetary units, number of prescriptions, units of drugs
dispensed, defined daily doses and prescribed daily doses, medication adherence measurement
2. Concept of risk in pharmacoepidemiology
Measurement of risk, attributable risk and relative risk, time-risk relationship 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 methods
Drug utilization review, case reports, case series, surveys of drug use, cross –
sectional studies, cohort studies, case control studies, case –cohort studies, meta – analysis studies,
spontaneous reporting, prescription event monitoring and record linkage system.
3. Sources of data for pharmacoepidemiological studies
Ad Hoc data sources and automated data systems.
Selected special applications of pharmacoepidemiology
Studies of vaccine safety, hospital pharmacoepidemiology, pharmacoepidemiology and risk
management, drug induced birth defects.
4. Phrmacoeconomics:
Definition, history, needs of pharmacoeconomic evaluations
Role in formulary management decisions
Pharmacoeconomic evaluation
Outcome assessment and types of evaluation
Includes theoretical aspects of various methods and practical study of various
methods with the help of case studies for individual methods: Cost – minimization, cost- benefit, cost
– effectiveness, cost utility
5. Applications of Pharmacoeconomics
Software and case studies
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