2. TESTS FOR TERATOGENICITY Under the guidence of bymiss meenu singh sumangali.masst. professor m.pharm department of pharmacology pharmacologycmrcp hyderabad
4. A teratogen is an agent that can produce a permanent alteration of structure or function in an organism exposed during embyronic or fetal life Teratogen:
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6. A given teratogen may be organ specific. It may be species specific. It can be dose specific. Basic Characteristics of teratogen:
7. Teratology: Teratology is the study of abnormalities of physiological development. It is often thought of as the study of human “birth defects”, but it is much broader than that, taking in other non-birth developmental stages, including “puberty “; and other non-human life forms, including plants.
16. Testing Protocols: Under the guidelines of FDA Under the guidelines of ICH
17. Tests under FDA: Multigenerational studies Single generational studies Segment I:Evaluation of Fertility and Reproductive Performance Segment II: Assessment of Developmental Toxicity Segment II: Postnatal Evaluation
18. Tests under ICH: Fertility Assessment Postnatal Evaluation and Pregnancy State Susceptibility Assessment of Developmental Toxicity
19. Multigenerational Study: Exposed shortly after weaning (30–40 days of age) Continuous exposure of a rodent species (usually mice) The animals are mated. F1 F2 F3 The measured parameters : Fertility Litter size Neonatal viability The effects of the test is monitored through each generation.
26. Alternative Test Methods: Micro mass test ( cells from the limb buds & brains of rat embroys) Whole embrio culture test(whole embryos of rats) Embryonic stem cell test