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Printable Handouts
Navigable Slide Index
- Introduction
- Presentation outline
- Pre FDA - life without regulations
- The patent medicine era
- Peruna - "A miracle cure"
- Principles of toxicology
- Dr. Harvey Wiley
- "The poison squad"
- Upton Sinclair's "The Jungle"
- 1906 pure food and drugs act
- Elixir Sulfanilamide - 1937
- 1938 food, drug and cosmetic act
- The Thalidomide tragedy
- Kefauver-Harris agreement
- History of the GLPs
- US government reaction
- Europe and Japan
- Evolution of the GLPs
- GxPs and drug development
- Main aspects of GLPs (1)
- Main aspects of GLPs (2)
- Regulatory references
- Early regulations and animal welfare
- Animal welfare in the 20th century
- Origination of the IACUC
- IACUC regulatory mandates
- IACUC responsibilities
- IACUC meetings
- IACUC membership
- Institutional representation
- IACUC meeting considerations
- IACUC protocol review
- IACUC review considerations
- 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
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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 October 13, 2024, from https://doi.org/10.69645/FBLO3904.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Peter Thomas has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
Toxicology testing standards: good laboratory practices and the institutional animal care committee
Published on July 30, 2009
48 min
A selection of talks on Pharmaceutical Sciences
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