• 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. Topics
3. Definition of DILI
4. Types of DILI
5. Mechanisms of DILI (1)
6. Mechanisms of DILI (2)
7. The case of acetominophen intoxication
8. Drugs that potentially cause liver injury
9. Safety withdrawals 1960-1999
10. Signals of DILI in drug development
11. Scope of DILI
12. Cost of drug development
13. Epidemiology of DILI (1)
14. Etiology of ALF in the USA
15. Tip of the iceberg
16. Epidemiology of DILI (2)
17. Clinical patterns of DILI
18. Image of a normal liver (1)
19. Image of a normal liver (2)
20. Hepatocellular liver injury (1)
21. Hepatocellular liver injury (2)
22. Biochemistry of hepatocellular injury
23. Cholestatic liver injury
24. Biochemistry of cholestatic injury
25. What comprises liver injury?
26. What comprises liver injury in 2008?
27. Adaptation to injury (tolerance)
28. Adaptation in DILI
29. Toxicity grading in clinical trials
30. Jaundice and DILI
31. Hepatocellular jaundice
32. Bile lakes and apoptotic hepatocytes
33. Acute hepatocellular jaundice
34. Cholestatic jaundice
35. Common "signatures" of DILI
36. Susceptibility factors for DILI
37. Key elements in diagnosis
38. Diagnosis of DILI
39. Causality assessment tools in DILI
40. Causality assessment
41. Management of DILI
42. Rumack-Matthew nomogram
43. Monitoring in clinical practice
44. DILIN
45. Summary
46. Thank you

Topics Covered

• Definition of drug induced liver injury (DILI)
• Types and mechanisms of DILI
• Safety withdrawals
• Signals of DILI in drug development
• Epidemiology of DILI
• Clinical patterns
• Hepatocellular liver injury
• Cholestatic liver injury
• What comprises liver injury?
• Adaptation to injury
• Toxicity grading in clinical trials
• Jaundice
• Common signatures of DILI
• Susceptibility factors for DILI
• Key elements in diagnosis
• Causality assessment tools
• Management of DILI
• Monitoring in clinical practice

Links

Series:

• Non-Clinical Testing for Toxicity of Pharmaceuticals

Categories:

• Clinical Practice
• Metabolism & Nutrition
• Pharmaceutical Sciences

Therapeutic Areas:

• Cardiovascular & Metabolic

Talk Citation

Publication History

• Published on July 30, 2009

Financial Disclosures

• Prof. Victor Navarro has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.