LEADER 02965nam 2200625 450 001 9910144253403321 005 20170816111605.0 010 $a3-527-64471-7 010 $a1-281-94710-5 010 $a9786611947101 010 $a3-527-62303-5 010 $a3-527-62304-3 035 $a(CKB)1000000000556677 035 $a(EBL)481855 035 $a(OCoLC)283799106 035 $a(SSID)ssj0000200553 035 $a(PQKBManifestationID)11184117 035 $a(PQKBTitleCode)TC0000200553 035 $a(PQKBWorkID)10220925 035 $a(PQKB)11112495 035 $a(MiAaPQ)EBC481855 035 $a(EXLCZ)991000000000556677 100 $a20160816h20082008 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aMedical product regulatory affairs $epharmaceuticals, diagnostics, medical devices /$fby John J. Tobin and Gary Walsh 210 1$aWeinheim, [Germany] :$cWiley-Blackwell,$d2008. 210 4$dİ2008 215 $a1 online resource (299 p.) 300 $aDescription based upon print version of record. 311 $a3-527-31877-1 320 $aIncludes bibliographical references at the end of each chapters and index. 327 $aMedical Product Regulatory Affairs; Contents; Preface; 1 The Aims and Structure of Regulations; 2 Regulatory Strategy; 3 Drug Discovery and Development; 4 Non-Clinical Studies; 5 Clinical Trials; 6 Marketing Authorisation; 7 Authorisation of Veterinary Medicines; 8 Variations to the Drug Authorisation Process; 9 Medical Devices; 10 Authorisation of Medical Devices; 11 Good Manufacturing Practice (GMP); 12 Oversight and Vigilance; Index 330 $aWritten in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field.Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices.Everything pharmacolog 606 $aDrugs$xLaw and legislation 606 $aPharmacy$xLaw and legislation 606 $aMedical instruments and apparatus$xLaw and legislation 608 $aElectronic books. 615 0$aDrugs$xLaw and legislation. 615 0$aPharmacy$xLaw and legislation. 615 0$aMedical instruments and apparatus$xLaw and legislation. 676 $a344.041 676 $a344.0416 700 $aTobin$b Jack$g(John J.),$0977324 702 $aWalsh$b Gary 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910144253403321 996 $aMedical product regulatory affairs$92226370 997 $aUNINA