LEADER 01389nam 2200385Ia 450 001 9910698982703321 005 20090616151206.0 035 $a(CKB)5470000002398046 035 $a(OCoLC)401360575 035 $a(EXLCZ)995470000002398046 100 $a20090616d2004 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $eQ1E evaluation of stability data 210 1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :$cCenter for Biologics Evaluation and Research,$d[2004] 215 $a18 pages $cdigital, PDF file 300 $aTitle from PDF title page (viewed on June 16, 2009). 300 $a"ICH". 300 $a"June 2004". 320 $aIncludes bibliographical references (page 17). 517 $aGuidance for industry 606 $aDrug stability$xTesting 615 0$aDrug stability$xTesting. 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 $a9910698982703321 996 $aGuidance for industry$93434577 997 $aUNINA