16. Juvenile Animal Toxicity Studies: Regulatory Expectations, Decision Strategies and Role in Paediatric Drug Development

  1. William J. Brock4,
  2. Kenneth L. Hastings5 and
  3. Kathy M. McGown6
  1. Melissa S. Tassinari1,
  2. Luc M. De Schaepdrijver2 and
  3. Mark E. Hurtt3

Published Online: 10 MAR 2013

DOI: 10.1002/9781118517000.ch16

Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations

Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations

How to Cite

Tassinari, M. S., De Schaepdrijver, L. M. and Hurtt, M. E. (2013) Juvenile Animal Toxicity Studies: Regulatory Expectations, Decision Strategies and Role in Paediatric Drug Development, in Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations (eds W. J. Brock, K. L. Hastings and K. M. McGown), John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9781118517000.ch16

Editor Information

  1. 4

    Brock Scientific Consulting, Montgomery Village, USA

  2. 5

    Sanofi, Bethesda, USA

  3. 6

    FoxKiser, USA

Author Information

  1. 1

    CDER, Office of New Drugs, FDA, Silver Spring, USA

  2. 2

    Johnson & Johnson, Belgium

  3. 3

    Pfizer, Groton, USA

Publication History

  1. Published Online: 10 MAR 2013
  2. Published Print: 12 APR 2013

ISBN Information

Print ISBN: 9780470745915

Online ISBN: 9781118517000

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Keywords:

  • decision making strategies;
  • juvenile animal toxicity studies;
  • medicinal products;
  • paediatric drug development;
  • regulatory testing

Summary

This chapter reviews the current regulatory expectations for the application of juvenile animal studies for the development of new medicinal products (drugs and biologics). Then, it discusses key considerations to determine when such a study is needed and to understand what the elements of study designs are to assure meaningful data. Selected case studies have been included to illustrate the core components of a juvenile animal toxicity study design. The chapter focuses on the needs for paediatric drug development but it should be noted that, with regards to environmental chemical exposure, the Environmental Protection Agency (EPA) and the Organization for Economic Cooperation and Development (OECD) also recognize the need to perform hazard assessments in juvenile animals based on chemical-specific concerns. While there are no harmonized test guidelines for juvenile animal studies at present from either the EPA or OECD, studies in juvenile animals are undertaken when specific end-points require evaluation.