LEADER 01471oam 2200385Ia 450 001 9910697095203321 005 20230902161649.0 035 $a(CKB)5470000002383946 035 $a(OCoLC)586037897 035 $a(EXLCZ)995470000002383946 100 $a20100329d1995 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $eimmediate release solid oral dosage forms : scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation 210 1$a[Rockville, Md.] :$cCenter for Drug Evaluation and Research,$d[1995] 215 $a1 electronic resource (26, 1 page) 300 $a"CMC 5"--prelim. p. 300 $a"November 1995." 320 $aIncludes bibliographical references (pages 25-26). 517 $aGuidance for industry 606 $aSolid dosage forms$xTesting$xDocumentation$zUnited States 606 $aDrugs$xTherapeutic equivalency$xDocumentation$zUnited States 615 0$aSolid dosage forms$xTesting$xDocumentation 615 0$aDrugs$xTherapeutic equivalency$xDocumentation 712 02$aCenter for Drug Evaluation and Research (U.S.) 801 0$bGPO 801 1$bGPO 801 2$bGPO 906 $aBOOK 912 $a9910697095203321 996 $aGuidance for industry$93434577 997 $aUNINA LEADER 01520nam 2200409Ia 450 001 9910698831903321 005 20090526152810.0 035 $a(CKB)5470000002397549 035 $a(OCoLC)351703644 035 $a(EXLCZ)995470000002397549 100 $a20090526d2003 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $erevised recommendations for donor and product management based on screening tests for syphilis 210 1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,$d[2003] 215 $ai, 10 pages $cdigital, PDF file 300 $aTitle from PDF title page (viewed on May 26, 2009). 300 $a"Draft guidance". 300 $a"June 2003". 320 $aIncludes bibliographical references (page 8). 517 $aGuidance for industry 606 $aBlood donors$xGovernment policy$zUnited States 606 $aBlood products$zUnited States$xEvaluation 606 $aSyphilis$zUnited States$xPrevention 615 0$aBlood donors$xGovernment policy 615 0$aBlood products$xEvaluation. 615 0$aSyphilis$xPrevention. 712 02$aCenter for Biologics Evaluation and Research (U.S.) 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910698831903321 996 $aGuidance for industry$93434577 997 $aUNINA