LEADER 01455nam 2200373Ia 450 001 9910697092703321 005 20230902161905.0 035 $a(CKB)5470000002383971 035 $a(OCoLC)587646051 035 $a(EXLCZ)995470000002383971 100 $a20100330d1997 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $enonsterile semisolid dosage forms : scale-up and postapproval changes : chemistry, manufacturing, and controls : in vitro release testing and in vivo bioequivalence documentation 210 1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,$d[1997] 215 $a1 electronic resource (30) pages 300 $a'SUPAC-SS." 300 $a"CMC 7." 320 $aIncludes bibliographical references (29). 517 $aGuidance for industry 606 $aDrugs$xDosage forms$zUnited States$xTesting 606 $aDrugs$xTherapeutic equivalency$xDocumentation$zUnited States 615 0$aDrugs$xDosage forms$xTesting. 615 0$aDrugs$xTherapeutic equivalency$xDocumentation 712 02$aCenter for Drug Evaluation and Research (U.S.) 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910697092703321 996 $aGuidance for industry$93434577 997 $aUNINA