LEADER 01493nam 2200373Ia 450 001 9910697093403321 005 20230902161549.0 035 $a(CKB)5470000002383964 035 $a(OCoLC)587585389 035 $a(EXLCZ)995470000002383964 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] $eSUPAC-MR : modified release solid oral dosage forms : scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing and in vivo bioequivalence documentation 210 1$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 (ii, 36, 6, 6 pages) 300 $a"CMC 8." 300 $a"September 1997." 320 $aIncludes bibliographical references (page 36). 517 $aGuidance for industry 606 $aSolid dosage forms$zUnited States$xTesting 606 $aDrugs$xTherapeutic equivalency$xDocumentation$zUnited States 615 0$aSolid dosage forms$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 $a9910697093403321 996 $aGuidance for industry$93434577 997 $aUNINA