JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY, KAKINADA

SYLLABUS for M.PHARMACY

PHARMACOLOGY AND TOXICOLOGY

I SEMESTER

Paper 101 - Modern Analytical Techniques

Paper 102 - Research Methodologies
Paper 103 - Systemic Pharmacology
Paper 104 - Pharmacokinetics and Drug Metabolism
Paper 105 - Systemic Pharmacology – LAB
Paper 106 - Pharmacokinetics and Drug Metabolism – LAB
Paper 107 - Seminar

II SEMESTER

Paper 201 - Advanced Pharmacology

Paper 202 - Toxicology
Paper 203 - Bioassays & Pharmacological Screening Methods
Paper 204 - Drug Regulatory Affairs
Paper 205 - Toxicology - LAB
Paper 206 - Bioassays & Pharmacological Screening Methods - LAB
Paper 207 - Seminar

III SEMESTER

Paper 301 - Project Seminar-I (On the proposed project work with aims and
objectives) - 50 Marks
Paper 302 - Project work - I

IV SEMESTER

Paper 401 - Project Seminar-II (On the experimentation and results of the
project work) – 50 Marks
Paper 402 - Project work - II
 SCHEME OF INSTRUCTIONS AND EVALUATION

PHARMACOLOGY AND TOXICOLOGY

FIRST SEMESTER

Evaluation / Marks

Paper Theory Practical

Title of the Paper Total Credits
No.
University University
Mid Mid
End End
Examination Examination
Examination Examination
Modern
Paper
Analytical 40 60 100 3
– 101
Techniques

Paper Research
40 60 100 3
– 102 Methodologies

Paper Systemic
40 60 100 3
– 103 Pharmacology

Pharmacokinetics
Paper
and drug 40 60 100 3
– 104
Metabolism

Systemic
Paper
Pharmacology – 40 60 100 2
– 105
Lab
Pharmacokinetics
Paper
and drug 40 60 100 2
– 106
Metabolism - Lab
Paper
Seminar 100 2
– 107

TOTAL 700 18
SECOND SEMESTER

Evaluation / Marks

Paper Title of the Theory Practical Total Credits

No. Paper
University University
Mid Mid
End End
Examination Examination
Examination Examination
Paper Advanced
40 60 100 3
– 201 Pharmacology

Paper
Toxicology 40 60 100 3
–202

Bioassays and
Paper Pharmacological
40 60 100 3
– 203 Screening
Methods
Drug
Paper
Regulatory 40 60 100 3
– 204
affairs

Paper Toxicology –
40 60 100 2
– 205 Lab

Bioassays and
Paper Pharmacological
40 60 100 2
– 206 Screening
Methods - Lab
Paper
Seminar 100 2
– 207

TOTAL 700 18
THIRD AND FOURTH SEMESTERS

Credits
Paper No. III Semester Total
***

Project Seminar – I (On the proposed

Paper - 301 50 2
project work with aims and objectives)

Paper - 302 ---- 20

Project work - I
Total 50 22

Credits
Paper No. IV Semester Total
***

Project Seminar – II (On the Completed

Paper - 401 project work) 50 2

Project work - II
Paper - 402 --- 20

TOTAL MARKS
50 22

GRAND TOTAL FOR THE COURSE 1500 80

 M.PHARM - I SEMESTER

PAPER 101: MODERN ANALYTICAL TECHNIQUES

(Paper Common for all Specializations)

Principles, instrumentation and applications of the following Instruments and Chromatographic

Techniques
Unit- I
i. UV- Visible spectrophotometry
ii. Infrared spectroscopy
iii. Spectrofluorimetry
Unit- II
i. NMR spectroscopy
ii. Electron Spin Resonance spectroscopy
iii. Atomic Emission spectroscopy
Unit- III
i. HPLC
ii. HPTLC
iii. Exclusion chromatography
iv. Super critical fluid chromatography
Unit- IV
i. Mass Spectroscopy including LCMS & GCMS
ii. GLC
Unit- V
i. Plasma Emission spectroscopy
ii. X-Ray diffractometry
iii. Optical Rotatory Diffusion
iv. Vapor phase chromatography
v. Affinity chromatography
vi. Ion-exchange chromatography

TEXT BOOKS
1. Practical Pharmaceutical Chemistry Vol. 1 &II by Beckett & Stenlake.
2. Instrumental Methods of Analysis by Scoog and West.
3. Instrumental Methods of Analysis by B.K.Sharma
4. Vogel’s text book of Quantitative Chemical Analysis.
5. Instrumental methods of Analysis by Willard & Merrit.
6. A text book of Pharmaceutical Analysis by K. A. Conners.

REFERENCE BOOKS
1. I.P.
2. B.P.
3. U.S.P.
4. Remington’s Pharmaceutical Sciences.
5. Spectroscopy by Silversterin
 PAPER 102: RESEARCH METHODOLOGIES
(Paper common for all Specializations)

UNIT - I
Statistical Methods:
Chance Variation – Probability Distribution - Normal Distribution – Sampling Distribution.
Error and its significance - Measures of Error - Control of Error in Experimental
Investigations – Problem Solving.

UNIT - II
Correlation and Regression, Multiple Regression - Problem Solving

UNIT - III
Tests of Significance: Principles, t-test, z-test, F-ratio test, Chi-square test. Non-parametric
tests - their applications in pharmacy research with examples – Problem Solving

UNIT - IV
Design of Experiments
Criteria of a good design with examples.
Principles - Randomization, replication and local control.
Study of CRD, RBD, LSD and factorial designs - their applications in Pharmacy research
with examples – Problem Solving

UNIT - V
Analysis of Variance (ANOVA) – one way, two way and three way – principles and
applications in pharmacy research - Problem Solving.
Optimization Techniques: Optimization Techniques based on Factorial Experiments - Problem
Solving.

Recommended Books:
1. Fundamentals of Biostatistics by Khan & Khanum, Ukaaz Publications, Hyderabad.
2. Theory & Practice of Industrial Pharmacy by Leon Lachman and Others.
3. Remington’s Practice of Pharmaceutical sciences, (Latest Edition).
4. Principles of Biostatistics by Marcello Pagnano, Published by Brooks/Cole, (Saurabh
Printers Pvt. Ltd).
5. Introduction to Biostatistics – A text book of biometry By Pranab Kumar Banerjee
 PAPER 103: SYSTEMIC PHARMACOLOGY
Unit – I
Basic principles of Pharmacology, Mechanisms of drug action, Receptor proteins, Types
and their molecular structure, Targets for G-Protein coupled receptors, protein
phosphorylation and kinase cascade mechanisms, cellular aspects-excitation, contraction
and secretion.
Pharmacology of Autonomic Nervous System
• Introduction and Physiology of autonomic nervous system, synthesis, release and
metabolism of ANS neurotransmitters.
• Muscarinic receptor agonists and antagonists.
• Anticholinergic agonists and antagonists.
• Agents acting at neuromuscular junction and autonomic ganglia.
• Neuromuscular blockers.

Unit – II
Drugs acting on Central Nervous System:
• Neurotransmitters and neurotransmission in central nervous system.
• Anti epileptics.
• Anti psychotics.
• Antidepressants.
• CNS stimulants.
• Hypnotics and sedatives.
• Opioid analgesics.
• Drug addiction and drug abuse.
• Analgesic, Antipyretic and Anti-inflammatory agents.
• Drugs acting on Parkinson’s disease.

Unit – III
Drugs acting on cardiovascular and renal systems:
• Cardiotonics.
• Anti – arrhythmics.
• Anti – hypertensives.
• Anti – anginal drugs.
• Anti – hyperlipidemic.
• Diuretics.
Drugs acting on the blood and blood – forming organs
• Hematopoietic agents : growth factors, minerals and vitamins.
• Blood coagulation and anti – coagulants, thrombolytics and anti – platelet drugs.

Unit – IV
Pharmacology of Chemotherapeutic and Anti-microbial agents
• General considerations of antimicrobial therapy.
• Sulfonamides, Trimethoprim, Quinolones, other related agents.
• Penicillins, Cephalosporins and other beta lactum anti-bacterial agents.
• Anti-fungal agents.
• Anti-viral agents.
 • Chemotherapy of Tuberculosis, Leprosy and Malaria.
• Chemotherapy of Protozoal infections.
• Antineoplastic agents, Immunosuppressants and Immunostimulants.

Unit – V
Hormones and their antagonists
• Pituitary hormones and their hypothalamic releasing factors.
• Thyroid and anti- thyroid drugs.
• Endocrine pancreas; Pharmacotherapy of Diabetes Mellitus.
• Estrogens and progestins.
• Androgens.

Recommended Books:
1. Pharmacology and Pharmacotherapeutics by R. S. Satoskar, S. D. Bhandarkar and S.S.
Ainapure.
2. The Pharmacological basis of therapeutics by Joel G. Hardman, Lee E. Limbird and
Alfred Goodman Gilman.
3. Pharmacology by H.P. Rang, M.M. Dale, J.M. Ritter & P.K. Moore.
4. Basic and Clinical Pharmacology by Bertram G. Katzung.
5. Pharmacology (Lippincott’s) by Mary J. Mycer, Richard A. Harvey and Pamela C.
Champe.
6. Essentials of Medical Pharmacology by K.D. Tripathi.
 PAPER 104: PHARMACOKINETICS AND DRUG METABOLISM

UNIT – I: Absorption
• Factors affecting drug absorption
• Gastrointestinal, percutaneous and rectal absorption
• Absorption kinetics, Wagner Nelson & Loo Riegelman methods
• Invitro methods of drug absorption (PAMPA and CACO2 models)
• Role of P- glycoprotein in drug absorption

Unit – II: Distribution

• Plasma protein binding , factors affecting plasma protein binding
• Tissue binding, kinetics of protein binding
• Transfer of drugs through biological membranes (Blood Brain Barrier, Placental
Barrier)

Unit – III: Metabolism

• Microsomal & Non microsomal biotransformations of drugs(Liver, Kidney and
kinetics)
• Physiological, Pathological factors affecting drug metabolism
• Genetic factors influencing drug metabolism
• First pass effect
• Human Cytochrome P450 enzyme ,Substrates,inducers and inhibitors of CYP 450
enzymes
• In Vitro methods of drug metabolism(Liver microsomes,Liver S9 fraction&Hepatocytes)

Unit – IV: Excretion

• Excretion of drugs by various routes
• Factors affecting excretion of drugs
• Enterohepatic recirculation
• Significance of elimination rate constant and elimination half life

Unit – V: Clinical Pharmacokinetics

• Basic concepts of clinical pharmacokinetics
• Therapeutic drug monitoring
• Population pharmacokinetics
• Drug interactions and their clinical significance
• Prediction of drug interactions
• Pharmacokinetic and pharmacodynamic modeling(PK/PD modelling)

Recommended Books:
1. Biopharmaceutics and pharmacokinetics - An Introduction by Robert E, Notari
2. Drug metabolism by Bernard Testa and Peter Jenner.
3. Selected chapters from Principles of drug action by Gold Stein, Aranow and Kalman.
4. Drug interaction by D. G. Grahme – Smith.
5. Remington’s Pharmaceutical Sciences
6. The Pharmacological basis of therapeutics by Joel G. Hardman, Lee E. Limbird and
Alfred Goodman Gilman
PAPER 105: SYSTEMIC PHARMACOLOGY – LAB

(Practicals based on theory)

PAPER 106: PHARMACOKINETICS AND DRUG METABOLISM – LAB

(Practicals based on theory)

 M.PHARM - II SEMESTER

PAPER 201: ADVANCED PHARMACOLOGY

Unit – I: Molecular Pharmacology

Pharmacology of receptors: Classification, cellular signaling systems, pharmacology of
agonists and antagonists of the following receptors
i. Excitatory amino acid receptors vi. Melatonin receptors
ii. Purinoreceptors vii. Adrenergic receptors
iii. GABA and Glycine receptors viii. Cholinergic receptors
iv. Neurosteroid receptors ix. Dopaminergic receptors
v. Cannabnoid receptors x. Serotonergic receptors.
Signalling Mechanisms: Physiological function, Pharmacological implications and
therapeutic potential of the following target sites:
i. Phosphoinositide 3 – kinase (PI3K) v. Protein kinases
ii. MAP Kinase vi. Phospho diesterases
iii. Caspases
iv. Peroxisome propliferator activator receptors (PPAR) – α and γ

Unit – II: Neuropeptides

A study of the mechanisms involved in the formation, release, possible physiological role,
pharmacological actions, agonists, antagonists and therapeutic potential of
i. Calcitonin gene related peptides iii. Substance P
ii. Neuropeptide Y iv. Cholecystokinin

Unit – III: Endogenous Mediators

i. Histamine v. Nitric Oxide
ii. Prostaglandins vi. Kinins
iii. Leukotrienes vii. 5-HT
iv. Opioid peptides

Unit – IV: Transporter Proteins

i. Classification and biology of ATP binding cassette (ABC) transporter superfamily.
ii. Multidrug resistance (MDR) proteins.

Unit – V:
i. Principles of clinical pharmacology and designs for testing of drugs in humans. Clinical
trials – Phases I, II, III, IV.
ii. Stem cells – Basic concepts and therapeutic applications in medicine.
iii. Free radicals, their biological role, endogenous anti-oxidant systems and their role in
tissue protection.

Recommended Books:
1. The Pharmacological basis of therapeutics by Joel G. Hardman, Lee E. Limbird and
Alfred Goodman Gilman.
2. Pharmacology by H.P. Rang, M.M. Dale, J.M. Ritter & P.K. Moore
3. Basic and Clinical Pharmacology by Bertram G. Katzung.
 4. Text book of Pharmacology by W. C. Bowman, M. J. Rand.

PAPER 202: TOXICOLGY

Unit – I:
History, scope of toxicology, principles of toxicology, mechanisms and risk assessment,
biotransformation of xenobiotics and toxicokinetics.

Unit – II:
Chemical Carcinogens:
Definitions, multistage carcinogenesis, mechanisms of action of chemical carcinogens
{genotoxic, mutagenesis, inorganic carcinogens (arsenic, beryllium, cadmium, chromium,
nickel, lead)}, test systems for carcinogenicity assessment (short-term tests for
mutagenicity – invitro & invivo gene mutation assays, chromosomal alterations, DNA
damage), chemical carcinogenesis in humans.

Unit - III
Target Organ Toxicity:
• Toxic responses of the blood.
• Toxic responses of immune system.
• Toxic responses of the liver.
• Toxic responses of the kidney.
• Toxic responses of the nervous system.
• Toxic responses of heart and vascular system.
• Toxic responses of the endocrine system.

Unit – IV:
Toxic Agents:
• Toxic effects of pesticides.
• Toxic effects of metals.
• Toxic effects of solvents and vapors.
• Toxic effects of plants.

Unit – V:
Environmental Toxicology:
• Air pollution.
• Ecotoxicology.
• Food toxicology.
• Clinical toxicology.

Recommended Books:
1. Casarett & Doull’s Toxicology The Basic Science of Poisons, Seventh edition. Editor-
Curtis D. Klaassen, Ph.D.
2. Niesink R.J.M. de Vries J and Hollingers M.A. Toxicology, Principal and Applications,
CRC Press1996.
3. Harrisons Principles of Internal Medicine. Medical Toxicology (Ellen Horns).
4. Toxicology – Principles and Applications, Raymond J.M.Niesink, John de.Vries,
Mannfred A. Hollinger.
5. Basis of Toxicology Testing Edited by Douald J Ecobichon.
 6. Ellenhorn‟s Medical toxicology 2nd Edition Williams and Wilkins, Baltimore, 1997.
7. Goldfrank’s Toxicological Emergencies , ninth edition.

PAPER 203: BIOASSAYS & PHARMACOLOGICAL SCREENING METHODS

Unit – I:
Principles of Experimental Pharmacology and Drug Discovery:
Common laboratory animals in Pharmacological research, Limitations of animal tests,
Alternatives to animal use, Anesthetics used in laboratory animals, some standard
techniques used in handling laboratory animals, Euthanasia of experimental animals.
Regulation for the care and use of laboratory animals.
Strategies and approaches employed in drug discovery. Basic concepts of Combinatorial
chemistry, High throughput screening, Cell lines and their applications in drug discovery.
Transgenic animal models in the development of new drugs.

Unit – II:
Principles of Biological standardization: Statistical treatment of modern problems in the
biological evaluation of drugs. Methods used in the bio-assays for antibiotics and
microbiological assays. Bioassay for Diphtheria antitoxin; Tetanus; Cholera vaccine;
Posterior Pituitary extract; Adrenaline; Heparin; Digitalis; d-Tubocurarine; Vitamins. Test
for pyrogens.
Bioassay methods for autocoids – Development of new bio-assay methods. Assays using
special designs for experiments to eliminate known source of variation. Toxicity tests,
Determination of LD50, Acute, Sub acute, and Chronic toxicity studies – Tests for freedom
from undue toxicity of drugs.

Unit - III:
Basic Principles of Screening and types – Simple, Blind and Programmed Screening. Need
for isolated tissues in pharmacological evaluation of drugs.
Organization of screening for the Pharmacological activity and evaluation of new
substances in CVS:
1. Diuretics
2. Antihypertensives
3. Antianginal agents
4. Anti arrhythmic agents and agents used in sudden cardiac failure
5. Druigs used in cardiomyopathies
6. Drugs used in hyperlipidemia and atherosclerosis
7. Anti infarct agents
Unit - IV:
Organization of screening for the Pharmacological activity and evaluation of new
substances in CNS:
1. Anti-epileptics
2. Anti-anxiety agents and Drugs used in mood and sleep disorders
3. Antipsychotics
4. Drugs affecting memory
5. Drugs used in Alzheimer’s disease
6. Local Anesthetics
7. Skeletal muscle relaxants and Neuromuscular blockers
Unit - V:
Organization of screening for the Pharmacological activity and evaluation of new
substances
1. Anti-diabetic agents
2. Analgesics and Drugs used in arthritis and neuropathic pain
3. Anti-Inflammatory agents
4. Anti-asthmatic agents
5. Anti-ulcer agents
6. Hepatoprotective agents

Recommended Books:
1. H.G.Vogel (ed),Drug Discovery and Evaluation- Pharmacological Assays,2nd Edition,
Springer verlag,Berlin,Germany,2002.
2. M.N.Gosh, Fundamentals of Experimental pharmacology,2nd Edition, Scientific Book
Agency,Culcutta,India,1985.
3. D.R.Laurence and A.L.Bacharach (Eds), Evaluation of Drug Activities:
Pharmacometrics, Volume I and II, Academic press,London,U.K,1964.
4. Biological Standardization by J.H.Burn, D.J.Finney and L.G. Goodwin.
5. Pharmacopoeias: IP,BP,USP
6. Screening methods in pharmacology by Robert A.Turner.
7. Methods in Pharmacology by Swarbrick.
 PAPER 204: DRUG REGULATORY AFFAIRS:
(Paper Common for all Specializations)

Unit - I
Formulation development: Regulatory requirements involved in the preformulation
studies, solid, liquid and semi-solid dosage forms, controlled release preparations,
injections and ocular preparations as per the European community, United States and
Indian regulatory authorities.

Unit - II
Manufacturing: Regulatory requirements as per European community, United States and
Indian regulatory authorities for manufacturing information, manufacturing formula,
process, validation of manufacturing process, equipment, documentation, inspection
requirement of regulatory guidelines for active ingredients, data requirement for new drug,
International aspects of Excipients, approval as per guidelines of all the territories.
Regulatory guidelines for packaging materials, test and evaluation of packaging materials,
biological test, elastometer test, microbiological test and evaluation of closures.

Unit - III
Stability testing: Scientific and technical background to the design of stability testing
regulatory requirements as per European community, United States and Indian regulatory
authorities for testing of new active substances, bulk active drug substances, dosage form in
their final packaging. Extension of shelf-life after authorization of drug international
harmonization and current guidelines. Regulatory affairs in respect of residual solvents as
per the ICH guidelines, analytical method validation, pharmacokinetic and toxicokinetic
validation.
Biopharmaceutics: Different testing parameters and standards as per regulatory
requirements of European community, United States and Indian regulatory authorities with
respect to factors related to formulation, dosage form, manufacturing process, stability and
storage.

Unit - IV
Preclinical aspects of Biopharmaceutics: Current guidelines and developments as per
regulatory requirements of European community, United States and Indian regulatory
authorities in respect of clinical bioavailability , study design, presentation documentation
and statistical analysis.
Clinical pharmacology and Pharmacodynamics: Regulatory guidelines as per European
community, United States and Indian regulatory authorities on clinical study design,
documentation, presentation and interpretation. Clinical trials: Definition, phase I, phase II,
phase III and phase IV studies, design documentation, presentation and interpretation,
statistical analysis of clinical data and factorial design.

Unit - V
Intellectual property rights and patents: Introduction, purpose, international scenario
and Indian scenario, guidelines as per European community, United States and Indian
 regulatory authorities, documentation, presentation and application, procedure for obtaining
and writing a patent and patenting rules and regulations.

Recommended Books:
1. Quality Assurance Guide by Organization of Pharmaceutical producers of India.
2. Drug formulation manual by D.P.S. Kohli and D.H.Shah. Eastern publishers, New
Delhi.
3. How to practice GMPs by P.P.Sharma. Vandhana Publications, Agra.
4. Pharmaceutical Process Validation by Fra. R. Berry and Robert A. Nash.
5. Pharmaceutical Preformulations by J.J. Wells.
6. Applied production and operations management by Evans, Anderson, Sweeney and
Williams.
7. Basic Principles of Clinical Research and Methodology by Gupta.
8. Biopharmaceutics and Clinical Pharmacokinetics-An introduction; 4th edition, Revised
and expanded by Robert. E. Notari, Marcel Dekker Inc, New York and Basel, 1987
 PAPER 205 - TOXICOLOGY LAB

(Practicals based on theory)

PAPER 206 - BIOASSAYS & PHARMACOLOGICAL SCREENING METHODS LAB

(Practicals based on theory)