Pediatric nonclinical drug testing : principles, requirements, and practices /

• Άλλοι συγγραφείς: Hoberman, Alan M., Lewis, Elise M.
• Μορφή: Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Hoboken, N.J. : John Wiley & Sons, [2012]
• Θέματα: Pediatric pharmacology > Research > United States.; Drugs > Toxicology > United States.; Drug Evaluation, Preclinical.; Age Factors.; Child.; Drug Approval.; Drug Toxicity > prevention & control.; Infant.; Models, Animal.; Läkemedelsutveckling.; United States.; Electronic books.

 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"--Provided by publisher. 

 Introduction / Elise M Lewis, Luc M De Schaepdrijver, Timothy P Coogan -- Overview of Pediatric Diseases and Clinical Considerations on Developing Medicines for Children / Bert Suys, Jose Ramet -- Nonclinical Safety Assessment for Biopharmaceuticals: Challenges and Strategies for Juvenile Animal Testing / Timothy P Coogan -- FDA Approach to Pediatric Testing / Robert E Osterberg -- Pediatric Drug Development Plans / Kimberly C Brannen, Beatriz Silva Lima -- Application of Principles of Nonclinical Pediatric Drug Testing to the Hazard Evaluation of Environmental Contaminants / Susan L Makris -- Nonclinical Testing Procedures-Pharmacokinetics / Loeckie L de Zwart, Johan G Monbaliu, Pieter P Annaert -- Preclinical Development of a Pharmaceutical Product for Children / Graham P Bailey, Timothy P Coogan, Luc M De Schaepdrijver -- Juvenile Toxicity Study Design for the Rodent and Rabbit / Alan M Hoberman, John F Barnett -- Dog Juvenile Toxicity / Keith Robinson, Susan Y Smith, Andre Viau -- Use of the Swine Pediatric Model / Paul C Barrow -- Juvenile Immunodevelopment in Minipigs / Andre H Penninks, Geertje J D van Mierlo, Frieke Kuper, Cor J Snel, Niels-Christian Ganderup, Andre P M Wolterbeek -- Use of Primate Pediatric Model / Gerhard F Weinbauer, Gary J Chellman, Allan Dahl Rasmussen, Elvira Vogelwedde -- Approaches to Rat Juvenile Toxicity Studies and Case Studies: a Pharmaceutical Perspective / Susan B Laffan, Lorraine Posobiec -- Appendix 1: Maturation of Organ Systems in Various Species -- Appendix 2: Sample Juvenile Toxicity Testing Protocol.