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Navigable Slide Index

1. Introduction
2. Talk objectives
3. Reproductive and developmental toxicology
4. Field background
5. Why is this field important?
6. Birth defects incidence
7. Birth defects - past examples
8. Guidance for testing
9. Defining the guidance for testing
10. Intentional and unintentional exposure
11. Underlying principles
12. Other underlying principles
13. Underlying principles - examples
14. Underlying principles - death or failure to thrive
15. Underlying principles - malformation
16. Underlying principles - growth retardation
17. Underlying principles - functional deficits
18. Basic guidelines
19. Basic guidelines - drugs
20. Chemicals (OECD or EPA- specific)
21. Foods and food additives
22. Guidance for intentional exposure (drugs)
23. Reproductive and developmental effects
24. ICH guidelines S5R - choice of studies
25. Unintentional exposure
26. Guidance for unintentional exposure
27. OECD guidelines for the testing of chemicals
28. Reproductive and developmental toxicity endpoints
29. Paternal/maternal endpoints
30. Reproductive endpoints
31. Developmental endpoints
32. Developmental endpoints - functional testing
33. Outcomes
34. Conclusions

Topics Covered

• Assessing the risk of exposure to a new pharmaceutical is critical in providing information on the safe and effective use of any new product
• Reproductive and developmental toxicology is the study of the potential adverse effect of a drug, chemical, consumer product or medical device on the ability of a male and female to produce healthy normal children
• Adverse outcomes have lead to the safety testing that is mandated
• The guidelines that outline the safety testing required, the principles that these guidelines are based on and the potential hazard assessments that are made are based on the test results

Links

Series:

• Non-Clinical Testing for Toxicity of Pharmaceuticals

Categories:

• Pharmaceutical Sciences
• Reproduction & Development

Therapeutic Areas:

• Gynaecology & Obstetrics

Talk Citation

Hoberman, A. and Lewis, E. (2009, July 30). Reproductive and developmental toxicology [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved May 30, 2023, from https://hstalks.com/bs/1343/.
Export Citation (RIS)

Publication History

• Published on July 30, 2009
• Archived on July 28, 2021

Financial Disclosures

• There are no commercial/financial matters to disclose.
• Dr. Elise Lewis has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.