Pediatric non-clinical drug testing: principles, requirements, and practice

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. INDICE: Chapter 1: Introduction and the History of Pediatric Nonclinical Drug Testing Elise M. Lewis, PhD, Luc M. deSchepdrijver, DVM, PhD, Msc, TimothyP. 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 Productfor 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 andJohn 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 Chapter13: 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

• ISBN: 978-0-470-44861-8
• Editorial: John Wiley & Sons
• Encuadernacion: Cartoné
• Páginas: 356
• Fecha Publicación: 24/02/2012
• Nº Volúmenes: 1
• Idioma: Inglés