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Pediatric Non-Clinical Drug Testing
Principles, Requirements, and Practice
Alan M. Hoberman (Edited by), AM Hoberman (Author), Elise M. Lewis (Edited by)
9780470448618, Wiley
Hardback, published 27 March 2012
384 pages
24.1 x 16.3 x 2.8 cm, 0.717 kg
“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)
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.
Preface ix Acknowledgments xi Contributors xiii 1. Introduction 1 2. Overview of Pediatric Diseases and Clinical Considerations on Developing Medicines for Children 29 3. Nonclinical Safety Assessment for Biopharmaceuticals: Challenges and Strategies for Juvenile Animal Testing 41 4. FDA Approach to Pediatric Testing 59 5. Pediatric Drug Development Plans 79 6. Application of Principles of Nonclinical Pediatric Drug Testing to the Hazard Evaluation of Environmental Contaminants 93 7. Nonclinical Testing Procedures—Pharmacokinetics 115 8. Preclinical Development of a Pharmaceutical Product for Children 129 9. Juvenile Toxicity Study Design for the Rodent and Rabbit 141 10. Dog Juvenile Toxicity 183 11. Use of the Swine Pediatric Model 213 12. Juvenile Immunodevelopment in Minipigs 231 13. Use of Primate Pediatric Model 255 14. Approaches to Rat Juvenile Toxicity Studies and Case Studies: a Pharmaceutical Perspective 281 Appendix 1 Maturation of Organ Systems in Various Species 301 Appendix 2 Sample Juvenile Toxicity Testing Protocol 303 Index 331
Elise M. Lewis, Luc M. De Schaepdrijver, and Timothy P. Coogan
Bert Suys and José Ramet
Timothy P. Coogan
Robert E. Osterberg
Kimberly C. Brannen and Beatriz Silva Lima
Susan L. Makris
Loeckie L. de Zwart, Johan G. Monbaliu, and Pieter P. Annaert
Graham P. Bailey, Timothy P. Coogan, and Luc M. De Schaepdrijver
Alan M. Hoberman and John F. Barnett
Keith Robinson, Susan Y. Smith, and Andre Viau
Paul C. Barrow
André H. Penninks, Geertje J.D. van Mierlo, Frieke Kuper, Cor J. Snel, Niels-Christian Ganderup, and André P.M. Wolterbeek
Gerhard F. Weinbauer, Gary J. Chellman, Allan Dahl Rasmussen, and Elvira Vogelwedde
Susan B. Laffan and Lorraine Posobiec
Subject Areas: Chemistry [PN]
