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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300   $a"Draft guidance."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