John Wiley & Sons Pediatric Non-Clinical Drug Testing Cover This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxi.. Product #: 978-0-470-44861-8 Regular price: $120.56 $120.56 In Stock

Pediatric Non-Clinical Drug Testing

Principles, Requirements, and Practice

Hoberman, Alan M. / Lewis, Elise M.

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1. Edition March 2012
384 Pages, Hardcover
Wiley & Sons Ltd

ISBN: 978-0-470-44861-8
John Wiley & Sons

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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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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.

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
Andre H. Penninks, Geertje J.D. van Mierlo, Frieke Kuper, Cor J. Snel, Niels-Christian Ganderup, and Andre 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
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.