Seminar on Teratogenicity by Sumaraja

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Seminar on Teratogenicity by Sumaraja

  1. 1. WELCOM<br />E<br />WELCOME<br />
  2. 2. TESTS FOR TERATOGENICITY<br /> Under the guidence of bymiss meenu singh sumangali.masst. professor m.pharm department of pharmacology pharmacologycmrcp hyderabad<br />
  3. 3. Teratogenicity:<br /> The capability of producing fetal malformation<br />
  4. 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<br />Teratogen:<br />
  5. 5.
  6. 6. A given teratogen may be organ specific.<br /> It may be species specific.<br /> It can be dose specific.<br />Basic Characteristics of teratogen:<br />
  7. 7. Teratology:<br />Teratology is the study of abnormalities of physiological development.<br /> 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.<br />
  8. 8. Critical periods:<br />
  9. 9.
  10. 10. Historical Teratogens:<br />Thalidomide<br /><ul><li>Accutane</li></ul>Diethylstilbestrol(DES)<br />Alcohol<br />
  11. 11. CLEFT LIP<br />
  12. 12. PHOCOMELIA<br />
  13. 13.
  14. 14. AMELIA / PHOCOMELIA<br />
  15. 15. TESTS FOR TERATOGENICITY<br />
  16. 16. Testing Protocols:<br /> Under the guidelines of FDA<br />Under the guidelines of ICH<br />
  17. 17. Tests under FDA:<br />Multigenerational studies<br />Single generational studies<br />Segment I:Evaluation of Fertility and Reproductive Performance<br />Segment II: Assessment of Developmental Toxicity<br />Segment II: Postnatal Evaluation<br />
  18. 18. Tests under ICH:<br />Fertility Assessment<br />Postnatal Evaluation and Pregnancy State Susceptibility<br />Assessment of Developmental Toxicity<br />
  19. 19. Multigenerational Study:<br />Exposed shortly after weaning (30–40 days of age)<br />Continuous exposure of a rodent species (usually mice)<br />The animals are mated. <br />F1<br />F2<br />F3<br />The measured parameters : Fertility<br /> Litter size<br /> Neonatal viability<br />The effects of the test is monitored through each generation.<br />
  20. 20. Evaluation of Fertility and Reproductive Performance:<br />
  21. 21. Assessment of Developmental Toxicity:<br />
  22. 22. Postnatal Evaluation:<br />
  23. 23. Fertility Assessment:<br />1.<br />3.<br />
  24. 24. Postnatal Evaluation and Pregnancy State Susceptibility:<br />
  25. 25. Assessment of Developmental Toxicity: <br />
  26. 26. Alternative Test Methods:<br />Micro mass test ( cells from the limb buds & brains of rat embroys)<br />Whole embrio culture test(whole embryos of rats)<br />Embryonic stem cell test<br />
  27. 27. Conclusions:<br /><ul><li> Understanding the mechanisms of the induction of birth defects is key to determine how to prevent these effects.
  28. 28. Further increasing the accuracy of experimental animal extrapolation will aid in the interpretation of experimental data in order to more accurately determine the risk of a given compound to elicit birth defects in humans</li></li></ul><li>Please, give only good fertilizer…<br />

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