Pediatric Nonclinical Drug Testing: Principles, Requirements, and Practices

• Year: 2012
• Tongue: English
• Leaves: 354
• Category: Library

✦ Synopsis

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.Content:
Chapter 1 Introduction (pages 1–27): Elise M. Lewis, Luc M. De Schaepdrijver and Timothy P. Coogan
Chapter 2 Overview of Pediatric Diseases and Clinical Considerations on Developing Medicines for Children (pages 29–39): Bert Suys and Jose Ramet
Chapter 3 Nonclinical Safety Assessment for Biopharmaceuticals: Challenges and Strategies for Juvenile Animal Testing (pages 41–57): Timothy P. Coogan
Chapter 4 FDA Approach to Pediatric Testing (pages 59–77): Robert E. Osterberg
Chapter 5 Pediatric Drug Development Plans (pages 79–92): Kimberly C. Brannen and Beatriz Silva Lima
Chapter 6 Application of Principles of Nonclinical Pediatric Drug Testing to the Hazard Evaluation of Environmental Contaminants (pages 93–113): Susan L. Makris
Chapter 7 Nonclinical Testing Procedures—Pharmacokinetics (pages 115–127): Loeckie L. de Zwart, Johan G. Monbaliu and Pieter P. Annaert
Chapter 8 Preclinical Development of a Pharmaceutical Product for Children (pages 129–139): Graham P. Bailey, Timothy P. Coogan and Luc M. De Schaepdrijver
Chapter 9 Juvenile Toxicity Study Design for the Rodent and Rabbit (pages 141–182): Alan M. Hoberman and John F. Barnett
Chapter 10 Dog Juvenile Toxicity (pages 183–212): Keith Robinson, Susan Y. Smith and Andre Viau
Chapter 11 Use of the Swine Pediatric Model (pages 213–229): Paul C. Barrow
Chapter 12 Juvenile Immunodevelopment in Minipigs (pages 231–254): Andre H. Penninks, Geertje J. D. van Mierlo, Frieke Kuper, Cor J. Snel, Niels?Christian Ganderup and Andre P. M. Wolterbeek
Chapter 13 Use of Primate Pediatric Model (pages 255–279): Gerhard F. Weinbauer, Gary J. Chellman, Allan Dahl Rasmussen and Elvira Vogelwedde
Chapter 14 Approaches to Rat Juvenile Toxicity Studies and Case Studies: a Pharmaceutical Perspective (pages 281–299): Susan B. Laffan and Lorraine Posobiec