• Introduction
• 29 min
  1. General introduction to non-clinical toxicity testing of pharmaceuticals

  • Dr. Andrea Weir
• 14 min
  2. Overview of nonclinical safety assessment

  • Dr. Claudette L. Fuller
• 12 min
  3. Biological safety testing: supporting medical device combination products

  • Dr. Christine L. Lanning
• 34 min
  4. Regulatory guidance on toxicity testing of pharmaceuticals: ICH

  • Dr. John Kapeghian
• 48 min
  5. Toxicology testing standards: good laboratory practices and the institutional animal care committee

  • Dr. Peter Thomas
• Basics of Non-clinical Toxicity Testing
• 20 min
  6. Acute, subchronic, and chronic toxicity testing

  • Mr. Gregory Ruppert
• 56 min
  7. Safety pharmacology in human pharmaceutical development

  • Dr. R. Dusty Sarazan
• 42 min
  8. Genetic toxicology

  • Dr. Roderick Todd Bunch
• 48 min
  9. Reproductive and developmental toxicology

  • Dr. Alan Hoberman
• 48 min
  10. Juvenile toxicity testing

  • Dr. Alan Hoberman
  • Dr. Elise Lewis
• 43 min
  11. Pharmacokinetics, toxicokinetics and safety margins

  • Dr. Mark Rogge
• 48 min
  12. Toxicity testing of impurities and metabolites

  • Dr. Kurt Black
• Organ System Toxicity Testing
• 38 min
  13. Drug induced liver injury: a clinical perspective

  • Prof. Victor Navarro
• 62 min
  14. Toxicology of the kidney

  • Prof. Lawrence Lash
• 58 min
  15. Toxicology of the cardiovascular system

  • Dr. Peter Siegl
• 67 min
  16. Toxicology of the immune system

  • Dr. Leigh Ann Burns Naas
• 59 min
  17. Toxicology of the developing immune system

  • Dr. Leigh Ann Burns Naas
• 43 min
  18. Hematology interpretation for toxicity studies

  • Dr. Nancy Everds
• New Methods for Assessing Toxicity
• 45 min
  19. Introduction to toxicogenomics and example case studies

  • Dr. Cindy Afshari
• Special Cases for Toxicity Testing
• 46 min
  20. Preclinical safety evaluation of biopharmaceuticals: science-based approach of facilitating clinical trials

  • Dr. Joy Cavagnaro
• 32 min
  21. Approaches to nonclinical vaccine development

  • Dr. Lisa Plitnick
• 54 min
  22. Toxicity testing of oncology drugs: unraveling the last 15 years of progress

  • Dr. Krishna Allamneni
• Archived Lectures *These may not cover the latest advances in the field
• 56 min
  23. Cellular and molecular toxicology

  • Dr. Dominic Williams
• 31 min
  24. Overview of non-clinical safety assessment in drug development

  • Dr. Danuta Herzyk
• 42 min
  25. Evaluation of the adult nervous system in preclinical studies

  • Dr. Mark Butt
• 56 min
  26. Non-clinical development of pharmaceuticals using engineered animal models

  • Dr. Brad Bolon
• 22 min
  27. Reproductive and developmental toxicology

  • Dr. Alan Hoberman
  • Dr. Elise Lewis
• 13 min
  28. Non-clinical toxicity testing for vaccines

  • Dr. Lisa Plitnick
• 36 min
  29. Toxicity testing for oncology drugs

  • Dr. Theresa Reynolds
  • Dr. Krishna Allamneni

Printable Handouts

PDF

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 December 30, 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.