Pediatric Nonclinical Drug Testing -- Contents -- Preface -- Acknowledgments -- Contributors -- 1. Introduction -- 2. Overview of Pediatric Diseases and Clinical Considerations on Developing Medicines for Children -- 3. Nonclinical Safety Assessment for Biopharmaceuticals: Challenges and Strategies for Juvenile Animal Testing -- 4. FDA Approach to Pediatric Testing -- 5. Pediatric Drug Development Plans -- 6. Application of Principles of Nonclinical Pediatric Drug Testing to the Hazard Evaluation of Environmental Contaminants -- 7. Nonclinical Testing Procedures-Pharmacokinetics -- 8. Preclinical Development of a Pharmaceutical Product for Children -- 9. Juvenile Toxicity Study Design for the Rodent and Rabbit -- 10. Dog Juvenile Toxicity -- 11. Use of the Swine Pediatric Model -- 12. Juvenile Immunodevelopment in Minipigs -- 13. Use of Primate Pediatric Model -- 14. Approaches to Rat Juvenile Toxicity Studies and Case Studies: a Pharmaceutical Perspective -- Appendix 1 Maturation of Organ Systems in Various Species -- Appendix 2 Sample Juvenile Toxicity Testing Protocol -- Index.