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Navigable Slide Index

1. Introduction
2. Overview
3. Objectives of general toxicology studies
4. Toxicology studies regulations and guidance
5. Good laboratory practices (GLPs)
6. GLP definition
7. ICH background
8. ICH guidance documents
9. ICH safety guidance documents
10. The core toxicology guidance: ICH M3 (R2)
11. Acute, subchronic, and chronic toxicity testing
12. Clinical trials study duration
13. Toxicology study duration
14. History of acute study requirements
15. Acute study components
16. Subchronic studies
17. Chronic studies
18. Subchronic/chronic study components
19. Traditional progression of repeat-dose studies
20. Alternative progression of repeat-dose studies
21. Why not choose the "one less study" path?
22. Study design considerations
23. Factors to consider before animal studies
24. Dose selection of novel compounds
25. Limit dose for general toxicity studies
26. Small vs. large molecules: general toxicology (1)
27. Small vs. large molecules: general toxicology (2)
28. Key takeaway messages

Topics Covered

• Purpose of acute, subchronic, and chronic general toxicology testing
• Regulations and guidelines on conduct
• Considerations and components to consider during study design
• Differences between small and large molecule toxicology study designs

Links

Series:

• Non-Clinical Testing for Toxicity of Pharmaceuticals

Categories:

• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on November 27, 2012
• Reviewed on April 12, 2022

Financial Disclosures

• Mr. Gregory Ruppert has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.