LEADER 01521nam 2200421Ia 450 001 9910696923303321 005 20230902161803.0 035 $a(CKB)5470000002383662 035 $a(OCoLC)558588044 035 $a(EXLCZ)995470000002383662 100 $a20100318d2009 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $eassay development for immunogenicity testing of therapeutic proteins 210 1$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:$cCenter for Biologics Evaluation and Research,$d[2009] 215 $a1 online resource (20 pages) $cillustrations 300 $a"Draft guidance." 300 $a"CMC." 300 $a"December 2009." 320 $aIncludes bibliographical references (pages 19-20). 517 $aGuidance for industry 606 $aImmunogenetics$zUnited States 606 $aBiological assay 606 $aProteins$xTherapeutic use$xTesting 615 0$aImmunogenetics 615 0$aBiological assay. 615 0$aProteins$xTherapeutic use$xTesting. 712 02$aCenter for Drug Evaluation and Research (U.S.) 712 02$aCenter for Biologics Evaluation and Research (U.S.) 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910696923303321 996 $aGuidance for industry$93434577 997 $aUNINA