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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.