JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objective

The students are going to study about various techniques for screening of drugs

for various pharmacological activities and guide lines for handling animals and human and animal ethics for screening of drugs.

Course Outcome

The expected outcomes are students will know how to handle animals and know

about various techniques for screening of drugs for different pharmacological activities, guidelines and regulations for screening new drug molecules on animals.

UNIT - I

Care Handling and breeding techniques of laboratory animals, Regulations for laboratory animals, CPCSEA guidelines, alternatives to animal studies, Good laboratory Practices.

UNIT - II

Bioassays: Basic principles of Biological standardization: Methods used in the bio-assay of Rabbis Vaccine, Oxytocin, Tetanus Antitoxin and Diphtheria Vaccine. Test for pyrogens.

UNIT - III

Toxicity tests: OECD guidelines, determination of LD50, acute, sub-acute and chronic toxicity studies.

UNIT - IV

Organization of screening for the Pharmacological activity of new substances with emphasis on the evaluation of cardiac and anti-diabetic activities.

UNIT - V

Organization of screening for the Pharmacological activity of new substances with emphasis on the evaluation of psychopharmacological, anti-inflammatory and analgesic activities.

TEXT BOOKS:

• 1. Screening methods in Pharmacology, Vol.-1&2 by Robert.A. Turner and Peter Hebborn.
• 2. Drug discovery and evaluation by H.G. Vogel and W.H. Vogel, Springerverlag, Berlin Heidelberg.
• 3. Handbook of experimental pharmacology by S.K. Kulkarni, Vallabh Prakashan, Delhi.
• 4. Guidelines and Screening Methods of Pharmacology, Surendra H. Bodakhe, Pharmamed Press.

REFERENCE BOOKS:

• 1. ICH of technical requirements for registration of pharmaceuticals for human use, ICH harmonized tripartite guidelines - Guidelines for good clinical practice, E6, May 1996.
• 2. Good clinical practice - Guidelines for Clinical trials on pharmaceutical products in India, Central drug standard control organization, New Delhi, Minister of Health- 2001. M.Pharm I Year II Sem (Pharmaceutical Chemistry)