000462938 000__ 03505cam\a2200385\a\4500 000462938 001__ 462938 000462938 005__ 20210513162117.0 000462938 006__ m\\\\\\\\d\\\\\\\\ 000462938 007__ cr\cn||||||||| 000462938 008__ 111018s2012\\\\njua\\\\sb\\\\000\0\eng\d 000462938 010__ $$z 2011043323 000462938 020__ $$z9780470448618 (cloth) 000462938 020__ $$z9781118168264 (e-book) 000462938 035__ $$a(CaPaEBR)ebr10630570 000462938 035__ $$a(OCoLC)823731502 000462938 040__ $$aCaPaEBR$$cCaPaEBR 000462938 043__ $$an-us--- 000462938 05014 $$aRM301.25$$b.P43 2012eb 000462938 08204 $$a615.7/040287$$223 000462938 24500 $$aPediatric non-clinical drug testing$$h[electronic resource] :$$bprinciples, requirements, and practice /$$cedited by Alan M. Hoberman, Elise M. Lewis. 000462938 260__ $$aHoboken, N.J. :$$bJohn Wiley & Sons,$$c2012. 000462938 300__ $$axv, 339 p. :$$bill. 000462938 504__ $$aIncludes bibliographical references. 000462938 5058_ $$aMachine generated contents note: Introduction and the history of pediatric nonclinical drug testing / Elise M. Lewis, Luc M. deSchepdrijver, Timothy P. Coogan -- Overview of pediatric diseases and clinical considerations on developing medicines for children / Bert Suys, Jose Ramet -- Nonclinical safety assessment for biopharmaceuticals : challenges and strategies for juvenile animal testing / Timothy P. Coogan -- FDA approach to pediatric testing / Robert E. Osterberg -- Pediatric drug development plans / Kimberly Brennan, Beatriz Silva Lima -- Application of principles of nonclinical pediatric drug testing to the hazard evaluation of environmental contaminants / Susan L. Makris -- Nonclinical testing procedures - pharmacokinetics / Loeckie L. de Zwart, Johan G. Monbaliu, and Pieter P. Annaert -- Preclinical development of a pharmaceutical product for children / Graham P. Bailey, Timothy P. Coogan, Luc M. De Schaepdrijver -- Juvenile toxicity study design for the rodent and rabbit / Alan M. Hoberman, and John Barnett Jr. -- Dog juvenile toxicity / Keith Robinson, Susan Y. Smith, and Andre Viau -- Use of the swine pediatric model / Paul C. Barrow -- Juvenile immuno-development in minipigs / Andre H Penninks ... [et al.] -- Use of primate pediatric model / Gerhard F. Weinbauer -- Approaches to rat juvenile toxicity studies and case studies : a pharmaceutical perspective / Susan B. Laffan, and Lorraine Posobiec. 000462938 506__ $$aAccess limited to authorized users. 000462938 520__ $$a"This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical trials, this text offers a comprehensive and up-to-date resource"--Provided by publisher. 000462938 650_0 $$aDrug development$$zUnited States. 000462938 650_0 $$aPediatric pharmacology$$zUnited States. 000462938 650_0 $$aPediatrics$$zUnited States$$xFormulae, receipts, prescriptions$$xSafety measures. 000462938 655_7 $$aElectronic books.$$2lcsh 000462938 7001_ $$aHoberman, Alan M. 000462938 7001_ $$aLewis, Elise M. 000462938 852__ $$bebk 000462938 85640 $$3ProQuest Ebook Central Academic Complete$$uhttps://univsouthin.idm.oclc.org/login?url=http://site.ebrary.com/lib/usiricelib/Doc?id=10630570$$zOnline Access 000462938 909CO $$ooai:library.usi.edu:462938$$pGLOBAL_SET 000462938 980__ $$aEBOOK 000462938 980__ $$aBIB 000462938 982__ $$aEbook 000462938 983__ $$aOnline