• 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. Toxicology of the cardiovascular system (1)
3. Toxicology of the cardiovascular system (2)
4. Drugs removed from market due to CV safety
5. Toxicology of the cardiovascular system (3)
6. Cardiovascular toxicity and adverse activity
7. Adverse outcomes
8. CV toxicology and safety pharmacology
9. Cardiovascular safety assessment: strategy
10. Types of nonclinical studies (1)
11. Acute and repeat-dose toxicology studies
12. Design of the GLP toxicology studies
13. Structural changes in heart (histopathology)
14. Cardiomyocyte's vacuolization after doxorubicin
15. Cardiac hypertrophy with rosiglitazone
16. Heart failure with rosiglitazone
17. Cardiotoxicity with rosiglitazone
18. Cardiotoxicity with rosiglitazone - benefit to risk
19. Strengths and limitations of toxicology studies
20. Problems and options of toxicology studies
21. Safety pharmacology studies
22. Safety pharmacology cardiovascular studies
23. In vitro IKr assay
24. In vitro ion channel assay
25. Screens for Ikr inhibitory activity
26. The GLP CV safety pharmacology studies
27. Canine telemetry
28. Canine external telemetry
29. Strengths and limitations of cardiovascular studies
30. Alternative cardiovascular assessment assays
31. Cardiovascular toxicology
32. Drug-induced Torsade de pointes
33. Drugs removed due to Torsade de pointes
34. In vivo QT interval duration
35. Screens for proarrhythmic risk
36. Case study: torcetrapib
37. ILLUMINATE results
38. Pharmacology investigation of torcetrapib (1)
39. Pharmacology investigation of torcetrapib (2)
40. Torcetrapib - summary and conclusions
41. Sibutramine hydrochloride monohydrate
42. SCOUT trial of sibutramine (1)
43. SCOUT trial of sibutramine (2)
44. Case study: sibutramine
45. Safety pharmacology cardio studies - conclusions
46. Types of nonclinical studies (2)
47. In vitro assays and screens
48. Safety testing in animal models of disease
49. Biomarkers and predictive toxicology studies
50. Biomarkers for cardiovascular toxicity (1)
51. Biomarkers for cardiovascular toxicity (2)
52. Biomarkers for cardiac toxicity
53. Ongoing clinical trial - biomarkers
54. Predictive cardiovascular toxicology
55. Summary
56. Thank you

Topics Covered

• Cardiovascular toxicities and adverse events in drug development programs
• CV drug removals from market
• Scientific perspective
• Regulatory perspective
• Strategies for minimising risks of CV toxicity in drug development programs
• Strategies for managing risks of CV toxicity in drug development programs

Links

Series:

• Non-Clinical Testing for Toxicity of Pharmaceuticals

Categories:

• Clinical Practice
• Pharmaceutical Sciences

Therapeutic Areas:

• Cardiovascular & Metabolic

Talk Citation

Publication History

• Published on July 31, 2011
• Reviewed on March 19, 2020

Financial Disclosures

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