000			03559nam a2200373 a 4500
001			ebr10630570
003			CaPaEBR
006			m u
007			cr cn|||||||||
008			111018s2012 njua sb 000 0 eng d
010			_z 2011043323
020			_z9780470448618 (cloth)
020			_z9781118168264 (e-book)
040			_aCaPaEBR _cCaPaEBR
035			_a(OCoLC)823731502
043			_an-us---
050	1	4	_aRM301.25 _b.P43 2012eb
082	0	4	_a615.7/040287 _223
245	0	0	_aPediatric non-clinical drug testing _h[electronic resource] : _bprinciples, requirements, and practice / _cedited by Alan M. Hoberman, Elise M. Lewis.
260			_aHoboken, N.J. : _bJohn Wiley & Sons, _c2012.
300			_axv, 339 p. : _bill.
504			_aIncludes bibliographical references.
505	8		_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.
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.
533			_aElectronic reproduction. _bPalo Alto, Calif. : _cebrary, _d2011. _nAvailable via World Wide Web. _nAccess may be limited to ebrary affiliated libraries.
650		0	_aDrug development _zUnited States.
650		0	_aPediatric pharmacology _zUnited States.
650		0	_aPediatrics _zUnited States _xFormulae, receipts, prescriptions _xSafety measures.
655		7	_aElectronic books. _2local
700	1		_aHoberman, Alan M.
700	1		_aLewis, Elise M.
710	2		_aebrary, Inc.
856	4	0	_uhttp://site.ebrary.com/lib/rucke/Doc?id=10630570 _zAn electronic book accessible through the World Wide Web; click to view
999			_c52808 _d52808