LEADER 04375nam 2200757 a 450 001 9910139706303321 005 20240514070204.0 010 $a9786613620255 010 $a9781280590429 010 $a1280590424 010 $a9781118168257 010 $a1118168259 010 $a9781118168226 010 $a1118168224 010 $a9781118168264 010 $a1118168267 035 $a(CKB)2550000000082779 035 $a(EBL)818510 035 $a(OCoLC)775301847 035 $a(SSID)ssj0000614481 035 $a(PQKBManifestationID)11366575 035 $a(PQKBTitleCode)TC0000614481 035 $a(PQKBWorkID)10604605 035 $a(PQKB)10896892 035 $a(MiAaPQ)EBC818510 035 $a(Au-PeEL)EBL818510 035 $a(CaPaEBR)ebr10630570 035 $a(CaONFJC)MIL362025 035 $a(OCoLC)823731502 035 $a(PPN)178706558 035 $a(OCoLC)757912391 035 $a(FINmELB)ELB179200 035 $a(Perlego)1010581 035 $a(EXLCZ)992550000000082779 100 $a20111018d2012 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aPediatric non-clinical drug testing $eprinciples, requirements, and practice /$fedited by Alan M. Hoberman, Elise M. Lewis 205 $a1st ed. 210 $aHoboken, N.J. $cJohn Wiley & Sons$d2012 215 $a1 online resource (370 p.) 300 $aDescription based upon print version of record. 311 08$a9780470448618 311 08$a047044861X 320 $aIncludes bibliographical references. 327 $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. 330 $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. 606 $aDrug development$zUnited States 606 $aPediatric pharmacology$zUnited States 606 $aPediatrics$zUnited States$xFormulae, receipts, prescriptions$xSafety measures 615 0$aDrug development 615 0$aPediatric pharmacology 615 0$aPediatrics$xFormulae, receipts, prescriptions$xSafety measures. 676 $a615.7/040287 701 $aHoberman$b Alan M$0925290 701 $aLewis$b Elise M$0925291 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910139706303321 996 $aPediatric non-clinical drug testing$92077548 997 $aUNINA