Pharmacological and Toxicological Screening Methods-II

THEORY 1.

Basic definition and types of toxicology (general, mechanistic, regulatory and descriptive) Regulatory guidelines for conducting toxicity studies OECD, ICH, EPA and Schedule Y OECD principles of Good laboratory practice (GLP) History, concept and its importance in drug development Hrs Acute, sub-acute and chronic- oral, dermal and inhalational studies as per OECD guidelines.

Acute eye irritation, skin sensitization, dermal irritation & dermal toxicity studies.

Test item characterization- importance and methods in regulatory toxicology studies Reproductive toxicology studies, Male reproductive toxicity studies, female reproductive studies (segment I and segment III), teratogenecity studies (segment II) Genotoxicity studies (Ames Test, in vitro and in vivo Micronucleus and Chromosomal aberrations studies) In vivo carcinogenicity studies IND enabling studies (IND studies)- Definition of IND, importance of IND, industry perspective, list of studies needed for IND submission.

Hrs Hrs Hrs Safety pharmacology studies- origin, concepts and importance of safety pharmacology.

Tier1- CVS, CNS and respiratory safety pharmacology, HERG assay. Tier2- GI, renal and other studies Toxicokinetics- Toxicokinetic evaluation in preclinical studies, saturation kinetics Importance and applications of toxicokinetic studies.

Alternative methods to animal toxicity testing.

Hrs