• 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. 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.