Pediatric Non-Clinical Drug Testing (eBook)

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.

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

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

"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)