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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.