03559nam a2200373 a 4500 ebr10630570 CaPaEBR m u cr cn||||||||| 111018s2012 njua sb 000 0 eng d 2011043323 9780470448618 (cloth) 9781118168264 (e-book) CaPaEBR CaPaEBR (OCoLC)823731502 n-us--- RM301.25 .P43 2012eb 615.7/040287 23 Pediatric non-clinical drug testing [electronic resource] : principles, requirements, and practice / edited by Alan M. Hoberman, Elise M. Lewis. Hoboken, N.J. : John Wiley & Sons, 2012. xv, 339 p. : ill. Includes bibliographical references. Machine generated contents note: Introduction and the history of pediatric nonclinical drug testing / Elise M. Lewis, Luc M. deSchepdrijver, 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 Brennan, 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, and 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, and John Barnett Jr. -- Dog juvenile toxicity / Keith Robinson, Susan Y. Smith, and Andre Viau -- Use of the swine pediatric model / Paul C. Barrow -- Juvenile immuno-development in minipigs / Andre H Penninks ... [et al.] -- Use of primate pediatric model / Gerhard F. Weinbauer -- Approaches to rat juvenile toxicity studies and case studies : a pharmaceutical perspective / Susan B. Laffan, and Lorraine Posobiec. "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. Electronic reproduction. Palo Alto, Calif. : ebrary, 2011. Available via World Wide Web. Access may be limited to ebrary affiliated libraries. Drug development United States. Pediatric pharmacology United States. Pediatrics United States Formulae, receipts, prescriptions Safety measures. Electronic books. local Hoberman, Alan M. Lewis, Elise M. ebrary, Inc. http://site.ebrary.com/lib/rucke/Doc?id=10630570 An electronic book accessible through the World Wide Web; click to view 52808 52808