LEADER 01479nam 2200409Ia 450 001 9910698987503321 005 20090615143102.0 035 $a(CKB)5470000002397997 035 $a(OCoLC)399838071 035 $a(EXLCZ)995470000002397997 100 $a20090615d2006 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $eQ3B(R2) impurities in new drug products 210 1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,$d[2006] 215 $a8 pages $cdigital, PDF file 300 $aTitle from PDF title page (viewed on June 15, 2009). 300 $a"ICH". 300 $a"July 2006" . 300 $a"Revision 2". 517 $aGuidance for industry 606 $aDrug development$xGovernment policy$zUnited States 606 $aDrug adulteration$xGovernment policy$zUnited States 615 0$aDrug development$xGovernment policy 615 0$aDrug adulteration$xGovernment policy 712 02$aCenter for Drug Evaluation and Research (U.S.) 712 02$aCenter for Biologics Evaluation and Research (U.S.) 712 12$aInternational Conference on Harmonisation. 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910698987503321 996 $aGuidance for industry$93434577 997 $aUNINA