Master of Pharmacy - Nagpur University

Subject code: MC-S8
Subject: BIOLOGICAL EVALUATION
THEORY: 60 Hours (4 hrs. /week)
1. Principles of Pharmacological and Pre-clinical Evaluation of drugs. Commonly used
laboratory animals in pharmacological research, limitations of animal tests Standard
techniques used in laboratory animals, euthanasia of experimental animals, Regulations for
laboratory animal care and ethical requirements.
2. Bioassays: Basic principles of bioassays, official bioassays, experimental models, design
of bioassays.
3. Toxicology: Principles of toxicity evaluations. Safety evaluation of new drugs in animals
including acute, sub-acute, sub chronic and chronic toxicity. ED50 and LD50 determination,
special toxicity test like teratogenecity and mutagenecity. Various guidelines for toxicity
studies. International guidelines and regulatory agencies for toxicity studies like ICH,
OECD, FDA, WHO etc.
4. Modern Methods of Pharmacological evaluations: Radioligand binding assay, patch
clamp, stereotaxic technique and ELISA. Recent advances in transgenic and genetically
modified animals for drug screening and other sophisticated methods
5. Alternatives to animal screening procedures: Cell line - handling, maintenance and
propagation of cell lines, their uses and limitations. In-vitro testing of drugs.
6. Preclinical Evaluation: Preclinical models employed and organization of screening of
new drugs of following categories:
i) Sedatives, hypnotics, anxiolytics, antidepressants, antipsychotics, nootropics,
antiparkinsonian agents, analgesics, antipyretics.
ii) Anti-inflammatory agents, anticonvulsants, local aneasthetics, CNS stimulants.
iii) Cardiac glycosides, antiarrhythmic, antihypertensive, antianginal, anti-
atherosclerotic,
iv) Antiulcer agents, Laxatives, Bronchodilators, antitussives,
v) Diuretics.
vi) Histamine antagonists.
vii) Muscle relaxants, Anticholinesterases, anticholinergics, adrenolytics.
viii) Hypoglycemics, antifertility agents, androgens.
ix) Anti-thyroid agents, Dermatological agents, Antitumor agents.
x) Anthelmintics, Antimalarials, Antileprotics.
xi) Drugs used for glaucoma, cataract and eye inflammation.
RECOMMENDED BOOKS:
1. Laurence D R and Bacharach A L, Evaluation of Drug Activities: Pharmacometrics,
Academic Press, London & New York.
2. Nodine J H and Siegler P E, Animal and Clinical Pharmacological Techniques in Drug
3. Evaluation, Year Book Medical Publishers Chicago.
4. Turner R A and Hebbron P, Screening Methods in Pharmacology, Vol I & II, Academic
Press, New York, 2009.
5. Vogel H G, Drug Discovery and Evaluation, Pharmacological Assays, Springer_verlog
Berlin Heidelberg, 2007.
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