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Navigable Slide Index

1. Introduction
2. Presentation outline
3. Nonclinical toxicity testing - history
4. Importance of nonclinical testing
5. Nonclinical guidances
6. Timing of vaccine safety assessment
7. Considerations in the design of toxicity studies
8. Selection of animal model
9. Vaccine formulation
10. Route and method of administration
11. Number of doses and dose levels
12. Types of nonclinical toxicity studies
13. Repeat-dose toxicity studies
14. DART with post-natal evaluation
15. Other toxicity studies
16. Case studies - prophylactic & therapeutic vaccine
17. Prophylactic vaccine example
18. Therapeutic vaccine example
19. Conclusions
20. Acknowledgements

Topics Covered

• Preclinical development
• Testing required prior to and in some cases concurrent with the administration of novel developmental candidates to volunteers and/or patients in clinical trials
• Vaccines
• Biologic entity designed to elicit a protective immune response
• May be prophylactic or therapeutic

Links

Series:

• Non-Clinical Testing for Toxicity of Pharmaceuticals

Categories:

• Pharmaceutical Sciences

Therapeutic Areas:

• Vaccines

Talk Citation

Publication History

• Published on July 30, 2009
• Archived on February 2, 2022

Financial Disclosures

• There are no commercial/financial matters to disclose.