Pediatric Non-Clinical Drug Testing. Principles, Requirements, and Practice

Description

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.

Table of Contents

• Chapter 1: Introduction and the History of Pediatric Nonclinical Drug Testing / Elise M. Lewis, PhD, Luc M. deSchepdrijver, DVM, PhD, Msc, Timothy P. Coogan, PhD, DABT
• Chapter 2: Overview of Pediatric Diseases and Clinical Considerations on Developing Medicines for Children / Bert Suys, MD, PhD, José Ramet, MD, PhD
• Chapter 3: Nonclinical Safety Assessment for Biopharmaceuticals: Challenges and Strategies for Juvenile Animal Testing / Timothy P. Coogan, PhD, DABT
• Chapter 4: FDA Approach To Pediatric Testing / Robert E. Osterberg, RPh, PhD, Fellow ATS
• Chapter 5: Pediatric Drug Development Plans / Kimberly Brennan, PhD, Beatriz Silva Lima, PharmD, PhD
• Chapter 6: Application of Principles of Nonclinical Pediatric Drug Testing to the Hazard Evaluation of Environmental Contaminants / Susan L. Makris, MS
• Chapter 7: Nonclinical Testing Procedures – Pharmacokinetics / Loeckie L. de Zwart, PhD, Johan G. Monbaliu, PhD and Pieter P. Annaert, RPharm. PhD
• Chapter 8: Preclinical Development of a Pharmaceutical Product for Children / Graham P. Bailey BSc, DipRC Path (Tox), Timothy P. Coogan, PhD, DABT, Luc M. De Schaepdrijver, DVM, PhD, MSc
• Chapter 9: Juvenile Toxicity Study Design for the Rodent and Rabbit / Alan M. Hoberman, PhD, DABT, Fellow ATS and John Barnett Jr, BS
• Chapter 10: Dog Juvenile Toxicity / Keith Robinson, Susan Y. Smith, MSc and Andre Viau, BSc
• Chapter 11: Use of the Swine Pediatric Model / Paul C. Barrow
• Chapter 12: Juvenile Immuno-development in Minipigs / André H Penninks PhD, ERT, Geertje J.D. van Mierlo, PhD, Frieke Kuper, PhD, Cor J. Snel, Bsc, Niels-Christian Ganderup, MSc and André P.M. Wolterbeek, PhD, ERT
• Chapter 13: Use of Primate Pediatric Model / Gerhard F. Weinbauer, Prof, PhD, Gary J. Chellman, PhD, DABT, Allan Dahl Rasmussen, PhD, DABT, ERT and Elvira Vogelwedde, Dipl Biol
• Chapter 14: Approaches to Rat Juvenile Toxicity Studies and Case Studies: A Pharmaceutical Perspective / Susan B. Laffan, PhD and Lorraine Posobiec, MS

• Appendices
• Appendix 1 Maturation of Organ Systems in Various Species
• Appendix 2 Sample Juvenile Toxicity Testing Protocol