JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objective

This subject is designed to impart the knowledge on preclinical evaluation of

drugs and recent experimental techniques in the drug discovery and development. The subject content helps the student to understand the maintenance of laboratory animals as per the guidelines, basic knowledge of various in-vitro and in-vivo preclinical evaluation processes

Course Outcome

Upon completion of the course the student shall be able to,

• Appraise the regulations and ethical requirement for the usage of experimental animals.
• Describe the various animals used in the drug discovery process and good laboratory practices in maintenance and handling of experimental animals
• Describe the various newer screening methods involved in the drug discovery process
• Appreciate and correlate the preclinical data to humans

UNIT - I

Laboratory Animals: Common laboratory animals: Description, handling and applications of different species and strains of animals. Transgenic animals: Production, maintenance and applications Anesthesia and euthanasia of experimental animals. Maintenance and breeding of laboratory animals. CPCSEA guidelines to conduct experiments on animals Good laboratory practice. Bioassay- Principle, scope and limitations and methods

UNIT - II

Preclinical screening of new substances for the pharmacological activity using in vivo, in vitro, and other possible animal alternative models. General principles of preclinical screening. CNS Pharmacology: behavioral and muscle co ordination, CNS stimulants and depressants, anxiolytics, anti-psychotics, anti epileptics and nootropics. Drugs for neurodegenerative diseases like Parkinsonism, Alzheimers and multiple sclerosis. Drugs acting on Autonomic Nervous System.

UNIT - III

Preclinical screening of new substances for the pharmacological activity using in vivo, in vitro, and other possible animal alternative models. Respiratory Pharmacology: anti-asthmatics, drugs for COPD and anti allergics. Reproductive Pharmacology: Aphrodisiacs and antifertility agents Analgesics, anti-inflammatory and antipyretic agents. Gastrointestinal drugs: anti ulcer, anti -emetic, antidiarrheal and laxatives.

UNIT - IV

Preclinical screening of new substances for the pharmacological activity using in vivo, in vitro, and other possible animal alternative models. Cardiovascular Pharmacology: antihypertensives, antiarrhythmics, antianginal, antiatherosclerotic agents and diuretics. Drugs for metabolic disorders like anti-diabetic, antidyslipidemic agents. Anti cancer agents. Hepatoprotective screening methods.

UNIT - V

Toxicology: Principles of Toxicology, Mutagenesis and Carcinogenesis. Teratogenecity & its mechanisms, Councelling of women about teratogenic risks. Acute and Subacute, Chronic toxicity studies

Classification of Poisons, Principles of Management of Acute Poisoning, General treatment of poisoning

REFERENCE BOOKS:

• 1. Biological standardization by J. H. Burn D.J. Finney and I.G. Goodwin
• 2. Screening methods in Pharmacology by Robert Turner. A
• 3. Evaluation of drugs activities by Laurence and Bachrach
• 4. Methods in Pharmacology by Arnold Schwartz.
• 5. Fundamentals of experimental Pharmacology by M. N. Ghosh
• 6. Pharmacological experiment on intact preparations by Churchill Livingstone
• 7. Drug discovery and Evaluation by Vogel H.G.
• 8. Experimental Pharmacology by R. K. Goyal.
• 9. Preclinical evaluation of new drugs by S. K. Gupta
• 10. Pharmacological Screening Methods & Toxicology by A. Srinivasa Rao
• 11. Handbook of Experimental Pharmacology, S K. Kulkarni
• 12. Practical Pharmacology and Clinical Pharmacy, S K. Kulkarni, 3rd Edition.
• 13. David R. Gross. Animal Models in Cardiovascular Research, 2nd Edition, Kluwer Academic Publishers, London, UK.
• 14. Screening Methods in Pharmacology, Robert A. Turner.
• 15. Rodents for Pharmacological Experiments, Dr. Tapan Kumar chatterjee.
• 16. Practical Manual of Experimental and Clinical Pharmacology by Bikash Medhi (Author), Ajay Prakash (Author) M.Pharm I Year II Sem (Pharmacology)