LEADER 01502nam 2200409Ia 450 001 9910698948703321 005 20090707143107.0 035 $a(CKB)5470000002398389 035 $a(OCoLC)422763322 035 $a(EXLCZ)995470000002398389 100 $a20090707d2001 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $eM4Q, the CTD, quality 210 1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,$d[2001] 215 $a29 pages $cdigital, PDF file 300 $aTitle from PDF title page (viewed on July 6, 2009). 300 $a"ICH". 300 $a"August 2001". 517 $aGuidance for industry 606 $aDrugs$xQuality control$xGovernment policy$zUnited States 606 $aDrug approval$xGovernment policy$zUnited States 606 $aClinical trials$xReporting$xGovernment policy$zUnited States 615 0$aDrugs$xQuality control$xGovernment policy 615 0$aDrug approval$xGovernment policy 615 0$aClinical trials$xReporting$xGovernment policy 712 02$aCenter for Drug Evaluation and Research (U.S.) 712 12$aInternational Conference on Harmonisation. 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910698948703321 996 $aGuidance for industry$93434577 997 $aUNINA