Pediatric Non-Clinical Drug Testing
Principles, Requirements, and Practice
1. Auflage März 2012
384 Seiten, Hardcover
Wiley & Sons Ltd
Kurzbeschreibung
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.
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.
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
ELISE M. LEWIS, PhD, is Director of Reproductive and Neurobehavioral Toxicology at Charles River Preclinical Services, Horsham, PA.
