Chapter 17. Nonclinical Safety Assessment of Vaccines and the Evaluation of Novel Adjuvants and Delivery Systems

  1. Manmohan Singh M. Pharm., Ph.D.
  1. Jose A. Lebron,
  2. Jayanthi J. Wolf,
  3. Catherine V. Kaplanski,
  4. Brian J. Ledwith

Published Online: 2 NOV 2006

DOI: 10.1002/9780470134931.ch17

Book Title

Vaccine Adjuvants and Delivery Systems

Vaccine Adjuvants and Delivery Systems

Additional Information

How to Cite

Lebron, J. A., Wolf, J. J., Kaplanski, C. V. and Ledwith, B. J. (2006) Nonclinical Safety Assessment of Vaccines and the Evaluation of Novel Adjuvants and Delivery Systems, in Vaccine Adjuvants and Delivery Systems (ed M. Singh), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470134931.ch17

Editor Information

  1. Novartis Vaccines, Emeryville, California, USA

Author Information

  1. Discovery and Biologics Safety Assessment, Merck Research Laboratories, West Point, Pennsylvania, USA

Publication History

  1. Published Online: 2 NOV 2006
  2. Published Print: 15 JUN 2007

ISBN Information

Print ISBN: 9780471739074

Online ISBN: 9780470134931

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Keywords:

  • nonclinical safety assessment testing strategy;
  • GLP-compliant nonclinical safety assessment;
  • quality control (QC) testing program

Summary

This chapter contains sections titled:

  • Introduction

  • Considerations for the Design of Nonclinical Safety Assessment Studies

  • Regulatory Expectations

  • Vaccine Lots Used in Nonclinical Safety Assessment Studies

  • Selection of an Animal Model for Nonclinical Safety Assessment Studies

  • Immunogenicity Evaluations within Nonclinical Safety Assessment Studies

  • Types of Nonclinical Safety Assessment Studies

  • Quality Control Testing Programs

  • Additional Considerations for the QC Testing of Vaccines

  • Conclusions

  • References

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