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Navigable Slide Index

1. Introduction
2. Outline of presentation
3. Background - impurities and metabolites
4. Impurities
5. Impurities - background
6. Types of API impurities
7. Regulatory and industry guidance
8. Highlights of ICH Q3A (API impurities) (1)
9. ICH thresholds for drug substance (API)
10. Highlights of ICH Q3A (API Impurities) (2)
11. ICH guidance recommended qualification studies
12. Strategies for in vivo qualification
13. In vivo qualification decision scheme
14. Decision scheme for qualification of API impurities
15. Alternatives to impurity qualification
16. Genotoxic impurities
17. Genotoxic impurities - background
18. Regulatory guidance on genotoxic impurities
19. Guidance on the limits of genotoxic impurities (1)
20. Guidance on the limits of genotoxic impurities (2)
21. Industry position paper on genotoxic impurities
22. Classification of impurities
23. CHMP question and answer document
24. Examples - limits based on genotoxic potential
25. Assessment of genotoxic potential of impurities
26. Decision scheme for qualification studies
27. Compound for genotoxicity qualification studies
28. Residual solvents
29. Residual solvents - background
30. ICH guidance Q3C - residual solvents
31. ICH Q3C residual solvents classes (1)
32. ICH Q3C residual solvents classes (2)
33. Limits for ICH class 2 solvents (1)
34. Limits for ICH class 2 solvents (2)
35. Drug product degradants
36. Drug product degradants - background
37. Impurities summary
38. Toxicity testing of metabolites
39. Metabolites - outline
40. Metabolites - background
41. Metabolites - definitions (1)
42. Metabolites - definitions (2)
43. Toxicity assessment of metabolites
44. Considerations during drug candidate selection
45. Industry position paper
46. Metabolites - regulatory guidance
47. FDA guidance - general considerations
48. General and reproductive toxicity studies
49. Genotoxicity and carcinogenicity studies
50. Considerations for direct testing of metabolites
51. Toxicity assessment of active human metabolites
52. Case studies - metabolites
53. Case study 1 - acyl glucuronide
54. Case study 2 - major, active metabolite
55. Case study 3 metabolite with structural alert (1)
56. Case study 3 metabolite with structural alert (2)
57. Toxicology testing of metabolites - summary
58. Summary - impurities and metabolites
59. Acknowledgments
60. References - impurities (1)
61. References - impurities (2)
62. References - metabolites

Topics Covered

• Types of impurities and regulatory framework
• Qualification of impurities
• Special considerations for genotoxic impurities
• Residual solvents and drug product degradants
• Safety assessment of drug metabolites

Links

Series:

• Non-Clinical Testing for Toxicity of Pharmaceuticals

Categories:

• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on July 30, 2009

Financial Disclosures

• Dr. Kurt Black has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.