Printable Handouts

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Navigable Slide Index

1. Introduction
2. Presentation outline
3. Pre FDA - life without regulations
4. The patent medicine era
5. Peruna - "A miracle cure"
6. Principles of toxicology
7. Dr. Harvey Wiley
8. "The poison squad"
9. Upton Sinclair's "The Jungle"
10. 1906 pure food and drugs act
11. Elixir Sulfanilamide - 1937
12. 1938 food, drug and cosmetic act
13. The Thalidomide tragedy
14. Kefauver-Harris agreement
15. History of the GLPs
16. US government reaction
17. Europe and Japan
18. Evolution of the GLPs
19. GxPs and drug development
20. Main aspects of GLPs (1)
21. Main aspects of GLPs (2)
22. Regulatory references
23. Early regulations and animal welfare
24. Animal welfare in the 20th century
25. Origination of the IACUC
26. IACUC regulatory mandates
27. IACUC responsibilities
28. IACUC meetings
29. IACUC membership
30. Institutional representation
31. IACUC meeting considerations
32. IACUC protocol review
33. IACUC review considerations
34. Further reading

Topics Covered

• The patent medicine era and the early role that toxicology played in drug and chemical safety
• Dr. Harvey Wiley, his "Poison Squad" and the Pure Food and Drugs Act that lead to the founding of the FDA in the 20th century
• Thalidomide, scientific fraud and the promulgation of the Good Laboratory Practices regulations
• Outrage over Upton Sinclair's book "The Jungle", the Animal Welfare Act and how this lead to the formation of Institutional Animal Care and Use Committees (IACUC)
• How study protocols are developed and GLP studies conducted with IACUC input and oversight

Links

Series:

• Non-Clinical Testing for Toxicity of Pharmaceuticals

Categories:

• Pharmaceutical Sciences

Talk Citation

Thomas, P. (2009, July 30). Toxicology testing standards: good laboratory practices and the institutional animal care committee [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved November 21, 2024, from https://doi.org/10.69645/FBLO3904.
Export Citation (RIS)

Publication History

• Published on July 30, 2009

Financial Disclosures

• Dr. Peter Thomas has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.