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Navigable Slide Index

1. Introduction
2. Scope of presentation
3. Why toxicology testing?
4. Role of safety assessment in drug development
5. Goals of nonclinical testing (1)
6. Goals of nonclinical testing (2)
7. Goals of nonclinical testing (3)
8. Key scientific disciplines within toxicology
9. Types of toxicology studies
10. Deciding what studies to perform
11. Regulation on non-clinical safety studies
12. ICH safety guidelines
13. Nonclinical safety guidelines for vaccines
14. Toxicology studies for first-in-human clinical trials
15. Genetic toxicology
16. Safety pharmacology studies - in vitro
17. Safety pharmacology studies - in vivo
18. General toxicology studies
19. Toxicology studies for late clinical development
20. Developmental and reproductive toxicology
21. Carcinogenicity studies
22. Nonclinical studies for marketing approval
23. Biologics as different class of pharmaceuticals
24. Regulation of biologics
25. Increasing levels of molecular complexity
26. Safety evaluation of biologics (1)
27. Safety evaluation of biologics (2)
28. Safety evaluation of biologics (3)
29. Are animal studies predictive of clinical outcome?
30. Summary
31. Acknowledgements

Topics Covered

• Toxicology studies of drug candidates as a critical part of safety evaluation in non-clinical and clinical development of new medicines
• Goals, types and extent of toxicity studies in different phases of drug development
• Comparison of small chemical drugs and large therapeutic molecules (biopharmaceuticals)

Links

Series:

• Non-Clinical Testing for Toxicity of Pharmaceuticals

Categories:

• Pharmaceutical Sciences

Talk Citation

Herzyk, D. (2010, August 9). Overview of non-clinical safety assessment in drug development [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved April 15, 2025, from https://doi.org/10.69645/CKKW9348.
Export Citation (RIS)

Publication History

• Published on August 9, 2010
• Archived on September 30, 2020

Financial Disclosures

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