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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.…mehr
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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Autorenporträt
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.
Inhaltsangabe
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
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
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