Teratogenicity refers to the ability of an agent to cause fetal malformations during embryonic or fetal development. A teratogen is an agent that can permanently alter the structure or function of an organism exposed during development. Teratogens may be organ-specific, species-specific, or dose-specific. Common teratogens include thalidomide, accutane, diethylstilbestrol, and alcohol. Tests for teratogenicity are conducted under FDA and ICH guidelines and include multigenerational studies, single generational studies, and assessment of developmental toxicity. Alternative test methods include micro mass tests, whole embryo culture tests, and embryonic stem cell tests. Understanding teratogenic mechanisms aids in birth defect

1. WELCOM E WELCOME

2. TESTS FOR TERATOGENICITY Under the guidence of bymiss meenu singh sumangali.masst. professor m.pharm department of pharmacology pharmacologycmrcp hyderabad

3. Teratogenicity: The capability of producing fetal malformation

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:

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.

8. Critical periods:

11. CLEFT LIP

12. PHOCOMELIA

14. AMELIA / PHOCOMELIA

15. TESTS FOR TERATOGENICITY

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.

20. Evaluation of Fertility and Reproductive Performance:

21. Assessment of Developmental Toxicity:

22. Postnatal Evaluation:

23. Fertility Assessment: 1. 3.

24. Postnatal Evaluation and Pregnancy State Susceptibility:

25. Assessment of Developmental Toxicity:

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