SCHEME OF STUDY

M.Phil (2 year) Pharmacology

2014-2016 and onward (Semester System)
YEAR-I SEMESTER –I
Course No. Course Title Credit
Hours
CC/M.Phil-501 Bio Statistics 2(2+0)
PCOL-502 Advanced concept of general 3(3+0)
Pharmacology
PCOL-503 Recent Advances in 3(3+0)
Ethnopharmacology
PCOL-504 Toxicological Screening Techniques 3(3+0)
PCOL-505 Pharmacology Lab. 1(0+1)
Total Credit Hours 12
SEMESTER-II
Course No. Course Title Credit
Hours
CC/M.Phil-502 Research Methodology 2(2+0)
PCOL-506 Clinical Pharmacology 3(3+0)
PCOL-507 Neuropsychopharmacology 3(3+0)
PCOL-508 Biochemical & Molecular 3(3+0)
Pharmacology
PCOL-509 Pharmacology Lab. 1(0+1)
Total Credit Hours 12
YEAR-II
SEMESTER –III & IV
Course No. Course Title Credit Hours
PCOL-601 Research & Thesis-I 6
PCOL-602 Research & Thesis -II 6
Total credit Hours 12

Total Credit Hours: 12+12+12+=36 CR

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M.Phil (2 year) PHARMACOLOGY

(SEMESTER SYSTEM)

YEAR-1

SEMESTER-I

CC/M.PhIL-501 BIOSTATISTICS 2(2+0)

Course Objectives:

After successful completion of this course, the students shall understand the use of bio-
statistics in biological & Pharmaceutical research and use of various test of significance and
their interpretation.

Course Contents:

Introduction: What is biostatistics? Application of statistics in biological and pharmaceutical

sciences Sample and population: Simple random sampling, sampling distribution and
standard error, stratified random sampling, systemic and cluster sampling Test of hypothesis
and significance: Statistical hypothesis and level of significance, test of significance,
confidence interval, test involving binomial and normal distribution Goodness of fit test: Chi-
square test distribution, it properties and applications, contingency tables, test of homogeneity
Student t test and f distribution: Properties of “f” and “t” distribution, test of significance
based on “t” and “f” distribution Analysis of variance: One way classification, partitioning of
sun of squares and degree of freedom, two way classification, multiple compression test such
as LSD, P-value, the analysis of variance model Experimental design (Advantages and
Disadvantages): basic principles of experimental designs, the completely randomized designs
(CR- Design), Randomized complete block design, Latin square design, factorial
experimental design, computer methods of statistical evaluation. Co-relation and regression
analysis

PCOL-502 ADVANCED CONCEPT OF GENERAL PHARMACOLOGY

3(3+0)

Course Objectives:
This course familiarize the students with the recent concepts and advances in the basic
principal in various field of pharmacology. They would understand the new concepts of
cellular as well as molecular pharmacology.

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Course Contents:
Drug receptor interaction theories,Receptor occupation and response relationship
Receptor characterization methods:Receptor down regulation and upregulation.
Structure activity relationships, Transmembrane signal mechanisms
Desensitization and tachyphylaxis,Drug dependence and withdrawal responses.
Cell proliferation and apoptosis.

PCOL-503 RECENT ADVANCES IN ETHNOPHARMACOLOGY 3(3+0)

Course Objectives:

This course will acquaint the post graduates students with the various fields of ethno
pharmacology. They would be able to critically analyze the research paper published in
various impact factor journals of ethnopharmacology. They will be able to write down the
review articles by consulting the data available in those journals. They will be familiar with
the techniques used in ethnopharmacological research. They will be comfortable to design a
project in this area for their dissertations.

Course Contents:

At least ten (10) research papers from impact factor journals in each of the following fields of
Ethnopharmacology would be discussed. They will particularly be focusing on the medicinal
plants having reported biological / pharmacology activities in the following diseases:

Metabolic disorders

Medicinal plants

Reproductive Steroids

Obesity, diabetics, hepataprotective etc.

Anti Arrtheritis, Analgesics, antipyretics

Anti Oxidants

Cardivascular diseases: congested heart failure, anti arrthymic, anti hypertensive

Psyconeuropharmacology such as anxiety, depression, alzymier, epilepsy, antimicrbials

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PCOL-504 TOXICOLOGICAL SCREENING TECHNIQUES 3(3+0)

Course Objectives:
After the completion of this course, the students would be familiarize with some of the
toxicological screening techniques used in drug discovery & development.
Course Contents:
Determination of Maximum Tolerated Dose (MTD) and LD50 . Allergenicity testing, dermal
toxicity. Cytotoxicity determination byMTT,LDH and neutral red uptake assay. Types of
genetic toxicity testing, AMES test, BCOP test, Comet assay, Embryonic stem cell test, Eye
irritation test, HET CAM, HPRT Assay, Mouse lymphoma assay, skin corrosion test, skin
irritation test , RBC test, Phototoxicity assay, photogenotoxicity assay, Surian Hamster
Embryo (SHE) cell transformation Assay

PCOL-505 PHARMACOLOGY LAB 1(0+1)

Course Objectives:
After the completion of this course, the students would be able to use various
pharmacological techniques used in recent pharmacological research. They would be
particularly focusing on the use of dry lab. as well as wet lab. in pharmacology.
Course Contents:
Principles of Experimental Pharmacology,
Common laboratory animals in pharmacological research, limitations of animal tests,
alternatives to animal use Regulations for the care and use of laboratory animals.
Experiments based on receptor occupancy and dose response relationship study, Bioassays,
experiment on intact animals & isolated tissues, aspects of bioavailability &
pharmacokinetics, spectroscopy, sophisticated chromatographic techniques.

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 SEMESTER-II

CC/M.Phil-502 RESEARCH METHODOLOGY 2(2+0)

Course Objectives:

This course will enable the students to choose the right path for doing research in various
field of pharmacology.

Course Contents:

Sources of Literature, Literature Survey, Reference Methodology, Writing techniques of

thesis, Data Analysts using statistical Techniques, Research & Clinical Ethics,
(TDR/PRD/ETHICS/2000.1 “Operational Guidelines for Ethics Committees That Review
Biomedical Research” by World Health Organization (WHO) Geneva 2000 Page No. 5
(4.5.2), Animal Use ethical Committees.

PCOL-506 CLINICAL PHARMACOLOGY 3(3+0)

Course Objectives:

After the successful completion of this course, the students will learn rational use of drugs for
the treatment of various diseases particularly related to female patients.

Course Contents:

Cardovascular & Renal on CVS. Asthama and drug induced lung diseases. Gastroenteritis,
Hepatitus, Jaundice & other Hepatic disorders. Endocrine & metabolic disorders (diabetes
mellitus, Osteoporois, Reproductive steroids, another related disorder.). Dermatological
disorders (acne, eczema, psoriasis & melanoma disorders (Hypertention, CHF & other
coronary disorders), adverse effects of cardiovascular drugs, drug induced skin problem)
Drug therapy in pregnant and breast feeding women, clinical pharmacokinetic &
Pharmacodynamic, nutrinutional problems in women, Pharmacoepidemology

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PCOL-507 NEUROPSYCHOPHARMACOLOGY 3(3+0)

Course Objectives:
This course will enable the students to understand the recent advances in pharmacology in the
field of Neuropsycopharmacology.
Course Contents:
Neurological disorders (Dementia, Sclerosis, Stroke) and Drugs induced neurological
disorders,
Drug addication, Narcotic Analgesics, Antipsychotics, Anti anxiety, Antidepressants, Anti-
Parkinsonism, Anti-Epileptics.
PCOL-508 BIOCHEMICAL AND MOLECULAR PHARMACOLOGY 3(3+0)

Course Objectives:

This course will develop an integrated approach in students. They will be able to explore and
integrate various disciplines of science such as physiology, pathology, microbiology, bio-
chemistry, biology and pharmacology and their importance in the drug development by using
recombinant DNA technology.

Course Contents:

Transcription and Translation of Genes, Neurohumoral Transmission and signal transduction

Separation, Purification and Characterization of Proteins, Nuclenic Acids and Phospholipids,
Sequenecing and Synthesis of Nuclic Acids and Peptides, Study of drugs metabolosium and
relevant enzyme, radio immunoassay, radio labeling, Flourescent Spectroscopy and
Immunodetection. Gene therapy, Recombinant DNA Technology and drugs prepared using
this thecnology. Animal tissue culture.
PCOL-509 PHARMACOLOGY LAB 1(0+1)

Course Objectives:
The students would be familiarize with various techniques used in of bio-chemical,
hematological, and molecular biology.
Course Contents:
Study of Hematological & Biochemical Parameters Level in patient’s blood.
Determination of toxicological parameters in patients’ blood or urine suffering with
nephrotoxicity, hepatotoxicity etc.(Total protein, Alkaline phosphatase, SGOT, SGPT,

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Creatinine, Urea Nitrogen, Uric Acid, bilirubin). Analysis of following urinary constituents in
patients: Na+, K+, Ca++, Glucose, Albumin, creatinine and other physiological factors
relationship with disease, clinical implication and interpretation,Determination of the
antibacterial spectrum of antibiotics (Determination of MIC & Zone of inhibition), Isolation
of plasmids,Isolation of DNA and RNA,Estimation of DNA and RNA,Polymerase Chain
reaction, Purification of PCR Products, Restriction digestion, Gel Electrophoresis Any other
practical/exercises related to pharmacology can be designed.

THIRD & FOURTH SEMESTER

PCOL-601 & PCOL-602
The research work will be carried out in any branch of Pharmacology. The thesis shall
embody the results of research, which may either be contribution to the existing knowledge
of the subject, or application of known methods of research to some technical problems.
These semesters will also include seminars and viva-voce examination concerning research
topics. Three copies of Research Thesis printed or type written shall be submitted for the
examination at the end of the fourth semester for evaluation and comprehensive examination.

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Recommended Books:

Sr. No. Title of Book Author Name

1. Rand & Dales’s Pharmacology 8th edition (IE) Rang/Dale

2. Clinical Pharmacy and Therapeutics 5th edition (IE) Walker R.

3. Basic and clinical Pharmacology 13th edition (IND/ED) Katzung B.G

4. Goodman & Gilman’s The Pharmacological basic of Laurence Brunton,

therapeutics 12th edition Bruce Chabner,
Bjorn Knollman

5. Richard D. Howland Pharmacology: Lippinote illmtneter

review

6. Singnal, K.C.Pharmacology Laboratory Manual I, II, 2nd

edition CBS, New Delhi; 1997

7. Nijkamp, F.P Principles of Immnopharmacology

Birlakhansarverlogy, Botton, 2005

8. Fox, Stuart I. Human Physiology. 13th edition, Mcgraw

9. Widmaiern, EP, Vender’s human Physiology 13th edition

MCGRAW HILL, 2011

10. Hansten, Philip D. Drug Interactive: Analysis & management

2014. Wolters Khawer

11. Watson, David. Pharmaceutical Analysis: AT.B of Pharmacy

students, Elsevier 2012

12. Pommerville, T.C. Alcamo’s Fundamentals of Microbiology

10th edition Jones & Bartlete.W.Y

13. Pillay, W modern medical toxicology 3rd edition Jaypee. New

Delhi; 2005

14. Hayes, A. Wallace. Principles and methods of toxicology 5th

edition infarma, N.Y. 2007

15. Barile, FranlaA. Principles of Toxicology testing. Infarma.

New York, 2007

16. Krishnan, Kannan. Quantitative modeling in toxicology

wiley. New York. 2010

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MODULE 1: PHARMACOKINETICS:
September 4th Introduction to Clinical Pharmacology and Pharmacokinetics
Clinical Applications of Pharmacokinetics J. Lertora (NIH-CC)
September 11th Chemical assay of drugs and drug metabolites S. Markey (NIH-NIMH)
September 18th Compartmental analysis of drug distribution J. Lertora (NIH-CC)
September 25th Use of positron emission tomography (PET) in pharmacokinetics R. Innis
(NIH-NIMH)
October 2nd Drug absorption and bioavailability J. Lertora (NIH-CC)
October 9th Effects of renal disease on pharmacokinetics J. Lertora (NIH-CC)
October 16th SPECIAL LECTURE: Pharmacokinetics in patients requiring
renal replacement therapy A. Atkinson (Northwestern Univ.) and
G. Susla (MedImmune, Inc)
October 23rd Noncompartmental vs. compartmental approaches to PK analysis P. Vicini
(Pfizer, Inc)
October 30th Effects of liver disease on pharmacokinetics J. Lertora (NIH-CC)
November 6th Population pharmacokinetics R. Miller (Daiichi Sankyo, Inc.)
MODULE 2: DRUG METABOLISM AND TRANSPORT:
November 13th Pathways of drug metabolism S. Markey (NIH-NIMH)
*Online Video Molecular, cellular and immunological basis of severe
adverse drug reactions (*View this material in course website) L. Pohl (NIH-NHLBI)
*Online Video Pharmacogenomics (*View this material in course website) D. Flockhart
(IUPUI)
December 11th Drug Interactions S. Robertson (Vertex Pharmaceuticals Inc)
January 8th SPECIAL LECTURE: P-glycoprotein and drug transport M. Gottesman (NIH-
OIR) and
M. Hall (NIH-NCI)
January 15th Equilibrative and concentrative drug transport J. Ware (Genentech, Inc.)
MODULE 3: ASSESSMENT OF DRUG EFFECTS:
*Online Video Dose response and concentration response analysis J. Lertora (NIH-CC)
(*View this material in course website)
January 22nd Developmental and pediatric pharmacology J. van den Anker (Children’s
National
Medical Center)

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January 29th Disease progression models and clinical trial simulation D. Mould (Projections
Research, Inc.)
MODULE 4: OPTIMIZING AND EVALUATING PATIENT THERAPY:
February 5th Physiological and laboratory markers of drug effect J. Woodcock (FDA-CDER)
*Online Video Clinical analysis of adverse drug reactions C. Chamberlain (FDA-CDER)
(*View this material in course website)
February 19th Drug therapy in pregnant and nursing women M. Frederiksen (Northwestern
Univ.)
February 26th Drug therapy in the elderly D. Abernethy (FDA-CDER)
March 5th Quality assessment of drug therapy C. Daniels (UCSD)
MODULE 5: DRUG DISCOVERY AND DEVELOPMENT:
March 12th Drug discovery E. Sausville (Univ. of Maryland Medical
System)
March 19th Nonclinical drug development C. Takimoto (Centocor R&D, Inc./Johnson &
Johnson)
March 26th Animal scale up and Phase I studies J. Collins (NIH-NCI)
April 2nd Development of biotechnology products and large molecules P. Garzone ((Pfizer,
Inc.)
April 9th Development and applications of cell based therapies D. Stroncek (NIH-CC)
April 16th Design of clinical drug development programs C. Breder (FDA-CDER)
April 23rd Role of the FDA in guiding drug development C. Peck (CDDS, UCSF

P 5220: Regulatory Issues in Drug Research

ECP 5620: Drug Metabolism and Disposition. Oxidative/conjugative enzymes systems

involved in human drug metabolism/disposition. Various in vitro models used to evaluate
drug metabolism or chemical entity, pros/cons of each. Factors involved in conducting in
vivo studies. Components used to predict in vivo drug disposition from in vivo studies.

ECP 8100: Seminar. Discussion of contemporary issues and research problems in the areas of
experimental and clinical pharmacology.

ECP 8200: Research problems. An individually designed research experience directed at

contemporary problems related to the drug use process.

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ECP 8220: Experimental and Clinical Pharmacology. Theory of advanced methodologies,
applications and evaluation techniques used to determine efficacy and toxicity of new drug
therapies. Advanced techniques for collecting and evaluating data.

ECP 8230: Advanced Topics in Experimental and Clinical Pharmacology. This is usually
taught by individuals who have an area of research in a particular topic.  Example topics
include: Pharmacometrics, Pharmacogenomics, Neuropharmacology

ECP 8400: Pharmacometrics. Theory and application of contemporary methods for analysis
of concentration-time data and exposure-response relationships.

ECP 8410: Population Pharmacokinetic Modeling. The pharmacokinetics and

pharmacodynamics of a drug in a population are frequently analyzed using nonlinear mixed-
effects model. This course will present the theoretical background for using a mixed effects
model in a population analysis and describe the process of building fixed and random effects
into a pharmacostatistical model. A project will allow the student to become familiar with a
contemporary population pharmacokinetic analysis program.

ECP 8420: Clinical Trial Simulation. Theory/application of contemporary methods of using

simulations to design more efficient/informative clinical trials.

ECP 8430: Advances in Pharmacometric Modeling and Simulation

ECP 8490: Advanced Topics in Pharmacometrics. Discussion and critical evaluation of new
techniques, issues and philosophies relating to Pharmacometrics that have appeared in recent
literature or at scientific/professional meetings.

Tasks primarily attached to OUH

The Drug Information: Patient-oriented counselling about drug-related questions to health
care staff.
The Drug Committee: Chairmanship and clinical pharmacological counselling functions.
GCP: Good Clinical Practice – quality assurance of clinical drug trials in humans
HEKLA: Hospital unit for quality-assured drug use at OUH.
TDM: Therapeutic Drug Monitoring – counselling with regard to drug analyses

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