Although the non–clinical and clinical testing needs of drugs for pediatric populations have been discussed and debated for more than forty years, many ethical, political, and practical issues remain unresolved, making pediatric drug testing and labeling a challenge for pharmaceutical and toxicology professionals. Written and edited by a team of leading international experts, this book explains both the importance and the practice of non–clinical pediatric drug testing. Moreover, it guides readers through the complex set of international rules and regulations governing the practice today.
Following the authors′ clear advice, readers will be able to meet FDA guidelines for non–clinical pediatric drug testing, from initial study design to submission of results for approval. Moreover, the authors describe key differences between the FDA guidelines and European Medicines Agency (EMA) legislation, enabling readers to devise and conduct studies, analyze the results, and then compile appropriate information for submission to both agencies.
Pediatric Non–Clinical Drug Testing offers clear guidance for managing the key challenges of non–clinical testing models, helping readers overcome the difficulties associated with:
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Lack of fully comparable models
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Inadequate historical experience
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Specific needs and effects associated with testing animals
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Practical problems using the clinical route of exposure in animal models
The book′s appendix features a sample juvenile toxicity testing protocol that readers can use as a template for their own experimental designs.
In addition to toxicologists and pharmacokineticists, this book is recommended for drug regulators who need to develop and enforce drug testing standards to protect children. It is also recommended as a textbook for toxicology and pediatric medicine courses.
Acknowledgments xi
Contributors xiii
1. Introduction 1Elise M. Lewis, Luc M. De Schaepdrijver, and Timothy P. Coogan
2. Overview of Pediatric Diseases and Clinical Considerations on Developing Medicines for Children 29Bert Suys and Jose Ramet
3. Nonclinical Safety Assessment for Biopharmaceuticals: Challenges and Strategies for Juvenile Animal Testing 41Timothy P. Coogan
4. FDA Approach to Pediatric Testing 59Robert E. Osterberg
5. Pediatric Drug Development Plans 79Kimberly C. Brannen and Beatriz Silva Lima
6. Application of Principles of Nonclinical Pediatric Drug Testing to the Hazard Evaluation of Environmental Contaminants 93Susan L. Makris
7. Nonclinical Testing Procedures Pharmacokinetics 115Loeckie L. de Zwart, Johan G. Monbaliu, and Pieter P. Annaert
8. Preclinical Development of a Pharmaceutical Product for Children 129Graham P. Bailey, Timothy P. Coogan, and Luc M. De Schaepdrijver
9. Juvenile Toxicity Study Design for the Rodent and Rabbit 141Alan M. Hoberman and John F. Barnett
10. Dog Juvenile Toxicity 183Keith Robinson, Susan Y. Smith, and Andre Viau
11. Use of the Swine Pediatric Model 213Paul C. Barrow
12. Juvenile Immunodevelopment in Minipigs 231Andr´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 255Gerhard F. Weinbauer, Gary J. Chellman, Allan Dahl Rasmussen and Elvira Vogelwedde
14. Approaches to Rat Juvenile Toxicity Studies and Case Studies: a Pharmaceutical Perspective 281Susan 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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Elise M. Lewis
