Description
Book SynopsisThis book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals.
Trade Review“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)
Table of ContentsPreface 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
