Preface

ix

Acknowledgments

xi

Contributors

xiii

1

Introduction   Elise M. Lewis, Luc M. De Schaepdrijver, and Timothy P. Coogan

1

2

Overview of Pediatric Diseases and Clinical Considerations on Developing Medicines for Children   Bert Suys and José Ramet

29

3

Nonclinical Safety Assessment for Biopharmaceuticals: Challenges and Strategies for Juvenile Animal Testing   Timothy P. Coogan

41

4

EDA Approach to Pediatric Testing   Robert E. Osterberg

59

5

Pediatric Drug Development Plans   Kimberly C. Brannen and Beatriz Silva Lima

79

6

Application of Principles of Nonclinical Pediatric Drug Testing to the Hazard Evaluation of Environmental Contaminants   Susan L. Makris

93

7

Nonclinical Testing Procedures—Pharmacokineties   Loeckie L. de Zwart, Johan G. Monbaliu, and Pieter P. Annaert

115

8

Preclinical Development of a Pharmaceutical Product for Children   Graham P. Bailey, Timothy P. Coogan, and Luc M. De Schaepdrijver

129

9

Juvenile Toxicity Study Design for the Rodent and Rabbit   Alan M. Hoherman and John F. Barnett

141

10

Dog Juvenile Toxicity   Keith Robinson, Susan Y. Smith, and Andre Viau

183

11

Use of the Swine Pediatric Model   Paul C. Barrow

213

12

Juvenile Immunodevelopment in Minipigs   Andre H. Penninks, Geertje J.D. van Mierlo, Frieke Kuper, Cor J. Snel Niels-Christian Ganderup, and André P.M. Wolterbeek

231

13

Use of Primate Pediatric Model   Gerhard F. Weinbauer, Gary J. Chellman, Allan Dahl Rasmussen and Elvira Vogelwedde

255

14

Approaches to Rat Juvenile Toxicity Studies and Case Studies: a Pharmaceutical Perspective   Susan B. Laffan and Lorraine Posobiec

281

Appendix 1

Maturation of Organ Systems in Various Species

301

Appendix 2

Sample Juvenile Toxicity Testing Protocol

303

Index

331