Pediatric Nonclinical Drug Testing: Principles, Requirements, and Practices

Pediatric Nonclinical Drug Testing: Principles, Requirements, and Practices

Editor(s): Alan M. Hoberman, Elise M. Lewis

Published Online: 11 JAN 2012 10:07AM EST

Print ISBN: 9780470448618

Online ISBN: 9781118168226

DOI: 10.1002/9781118168226

About this Book

This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical trials, this text offers a comprehensive and up-to-date resource.

Table of contents

    1. You have free access to this content
    2. Chapter 1

      Introduction (pages 1–27)

      Elise M. Lewis, Luc M. De Schaepdrijver and Timothy P. Coogan

    3. Chapter 12

      Juvenile Immunodevelopment in Minipigs (pages 231–254)

      André H. Penninks, Geertje J. D. van Mierlo, Frieke Kuper, Cor J. Snel, Niels-Christian Ganderup and André P. M. Wolterbeek

    4. Chapter 13

      Use of Primate Pediatric Model (pages 255–279)

      Gerhard F. Weinbauer, Gary J. Chellman, Allan Dahl Rasmussen and Elvira Vogelwedde

    5. You have free access to this content
    6. You have free access to this content
    7. You have free access to this content

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