Pediatric Non-Clinical Drug Testing (eBook, ePUB)

Principles, Requirements, and Practice
Redaktion: Hoberman, Alan M.; Lewis, Elise M.

• Format: ePub

Produktbeschreibung

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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Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 356
• Erscheinungstermin: 28. Dezember 2011
• Englisch
• ISBN-13: 9781118168257
• Artikelnr.: 37345777

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 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