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Pediatric Non-Clinical Drug Testing: Principles, Requirements, and Practice

Alan M. Hoberman (Editor), Elise M. Lewis (Editor)
ISBN: 978-0-470-44861-8
356 pages
March 2012
Pediatric Non-Clinical Drug Testing: Principles, Requirements, and Practice (047044861X) cover image


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.
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Table of Contents

Preface ix

Acknowledgments xi

Contributors xiii

1. Introduction 1
Elise M. Lewis, Luc M. De Schaepdrijver, and Timothy P. Coogan

2. Overview of Pediatric Diseases and Clinical Considerations on Developing Medicines for Children 29
Bert Suys and Jose Ramet

3. Nonclinical Safety Assessment for Biopharmaceuticals: Challenges and Strategies for Juvenile Animal Testing 41
Timothy P. Coogan

4. FDA Approach to Pediatric Testing 59
Robert E. Osterberg

5. Pediatric Drug Development Plans 79
Kimberly C. Brannen and Beatriz Silva Lima

6. Application of Principles of Nonclinical Pediatric Drug Testing to the Hazard Evaluation of Environmental Contaminants 93
Susan L. Makris

7. Nonclinical Testing Procedures—Pharmacokinetics 115
Loeckie L. de Zwart, Johan G. Monbaliu, and Pieter P. Annaert

8. Preclinical Development of a Pharmaceutical Product for Children 129
Graham P. Bailey, Timothy P. Coogan, and Luc M. De Schaepdrijver

9. Juvenile Toxicity Study Design for the Rodent and Rabbit 141
Alan M. Hoberman and John F. Barnett

10. Dog Juvenile Toxicity 183
Keith Robinson, Susan Y. Smith, and Andre Viau

11. Use of the Swine Pediatric Model 213
Paul C. Barrow

12. Juvenile Immunodevelopment in Minipigs 231
Andr´e H. Penninks, Geertje J.D. van Mierlo, Frieke Kuper, Cor J. Snel, Niels-Christian Ganderup, and Andr´e P.M. Wolterbeek

13. Use of Primate Pediatric Model 255
Gerhard F. Weinbauer, Gary J. Chellman, Allan Dahl Rasmussen and Elvira Vogelwedde

14. Approaches to Rat Juvenile Toxicity Studies and Case Studies: a Pharmaceutical Perspective 281
Susan B. Laffan and Lorraine Posobiec

Appendix 1 Maturation of Organ Systems in Various Species 301

Appendix 2 Sample Juvenile Toxicity Testing Protocol 303

Index 331

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Author Information

ALAN M. HOBERMAN, PhD, DABT, Fellow ATS, is Executive Director of Site Operations and Toxicology at Charles River Preclinical Services, Horsham, PA.

ELISE M. LEWIS, PhD, is Director of Reproductive and Neurobehavioral Toxicology at Charles River Preclinical Services, Horsham, PA.

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“Overall, this is a very useful book in bringing together many of the aspects associated with JA toxicology testing of pharmaceuticals for the first time, especially for those new to this growing field, with the chapters on study design considerations being especially useful.”  (British Toxicology Society New, 1 November 2012)

“The book is an essential reference for international regulatory personnel, toxicologists, pharmacokineticists, scientists working in the pharmaceutical industry, academics and physicians and pharmacists concerned about the safe use of medicines in children.”  (Pharmaceutical Journal, 11 September 2012)

“No other single resource combines pediatric drug development considerations with the most recent regulatory requirements and the approach to selecting and testing in nonclinical models. This is a unique and comprehensive reference that will inform and guide readers through the challenges and approaches to the safe and effective use of medications in children.”  (Doody’s, 17 August 2012)



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