03323nam 2200613 a 450 991080840520332120240313154333.01-118-51700-81-299-24266-91-118-51701-6(CKB)2670000000335822(EBL)1132837(OCoLC)829459871(SSID)ssj0000833771(PQKBManifestationID)11411977(PQKBTitleCode)TC0000833771(PQKBWorkID)10936154(PQKB)10913476(MiAaPQ)EBC1132837(Au-PeEL)EBL1132837(CaPaEBR)ebr10667420(CaONFJC)MIL455516(PPN)178990264(EXLCZ)99267000000033582220121126d2013 uy 0engur|n|---|||||txtccrNonclinical safety assessment a guide to international pharmaceutical regulations /edited by William J. Brock, Kenneth L. Hastings, Kathy M. McGown1st ed.Chichester, West Sussex John Wiley & Sons20131 online resource (487 p.)Description based upon print version of record.0-470-74591-6 Includes bibliographical references and index.Introduction to the development of drugs / Kathy McGown -- ICH / Ken Hastings -- USFDA / Bill Brock -- Latin America : MERCOSUR countries / Cristiana Leslie Corra -- Canada / Mark T. Goldberg -- EMEA / Adam Woolley -- Africa / Fariza Feraoun -- China / Lijie Fu -- Japan / Kazuichi Nakamura -- India / K.S. Rao -- Australia / Doug Francis -- Chronic repeat dose testing / Shana Azri-Meehan -- Carcinogenicity / James Popp -- Genotoxicity / Mark Powley -- Developmental and reproductive toxicology / Robert Parker -- Juvenile testing and pediatric claim / Melissa Tassinari -- Immunotoxicology / Leigh Ann Burns Naas -- Biologics / Chris Ellis -- Vaccines / Robert House -- Phototoxicity and photocarcinogenicity / Chris Sambuco -- Degradants, impurities excipients, and metabolites / Bob Osterberg.Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practiDrug developmentInternational cooperationDrugsToxicologyInternational cooperationDrug developmentInternational cooperation.DrugsToxicologyInternational cooperation.615.1/901Brock William J292040Hastings Kenneth L1603351McGown Kathy M1603352MiAaPQMiAaPQMiAaPQBOOK9910808405203321Nonclinical safety assessment3927682UNINA