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 José 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
André H. Penninks, Geertje J.D. van Mierlo, Frieke Kuper, Cor J.
Snel, Niels-Christian Ganderup, and André 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 ExecutiveDirector of Site Operations and Toxicology at Charles RiverPreclinical Services, Horsham, PA. ELISE M. LEWIS, PhD, is Director of Reproductive andNeurobehavioral Toxicology at Charles River Preclinical Services,Horsham, PA.
Overall, this is a very useful book in bringing togethermany of the aspects associated with JA toxicology testing ofpharmaceuticals for the first time, especially for those new tothis growing field, with the chapters on study designconsiderations being especially useful. (BritishToxicology Society New, 1 November 2012) The book is an essential reference for internationalregulatory personnel, toxicologists, pharmacokineticists,scientists working in the pharmaceutical industry, academics andphysicians and pharmacists concerned about the safe use ofmedicines in children. (PharmaceuticalJournal, 11 September 2012) No other single resource combines pediatric drugdevelopment considerations with the most recent regulatoryrequirements and the approach to selecting and testing innonclinical models. This is a unique and comprehensive referencethat will inform and guide readers through the challenges andapproaches to the safe and effective use of medications inchildren. (Doody s, 17 August 2012)
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