• 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. Agenda
3. Genetic toxicology: background
4. Bacterial reverse mutation assay (Ames assay) (1)
5. In vitro mammalian chromosome aberration assay
6. CHO cell cytogenetic assay - aberrations
7. CHO cell cytogenetic assay - polyploidy
8. The MN assay as a surrogate for cytogenetics
9. In vitro mammalian gene mutation test
10. In vivo genotoxicity assays
11. Current practices and future directions
12. Genotoxicity assays - the standard battery (ICH)
13. Bacterial reverse mutation assay (Ames assay) (2)
14. Ames assay, sample results
15. In vitro chromosome aberration assay
16. In vitro mammalian cell gene mutation assays
17. In silico (computational) SAR
18. Genotoxicity testing during development
19. Integration of genetox study results
20. Issue management - positive responses
21. Interpreting genetox toxicity results
22. Genetic toxicity - case study
23. Mechanistic use of the aberration assay
24. Influence on carcinogenicity testing
25. EMEA guidance for genotoxic impurities
26. Staged TTC approach
27. Summary
28. References
29. Thank you

Topics Covered

• Mutagenicity testing
• Clastogenicity testing
• Additional assays
• Regulatory genetic toxicology
• Current regulations
• In vitro mutagenicity and clastogenicity
• In silico
• Integration of results and data interpretation
• Genotoxic impurity testing

Links

Series:

• Non-Clinical Testing for Toxicity of Pharmaceuticals

Categories:

• Genetics & Epigenetics
• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on July 30, 2009

Financial Disclosures

• Dr. Roderick Todd Bunch has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.