LEADER 01469oam  2200385Ia 450 
001 9910698731603321
005 20090421151936.0
035   $a(CKB)5470000002396542
035   $a(OCoLC)318922997
035   $a(EXLCZ)995470000002396542
100   $a20090421d2008      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $esafety, efficacy, and pharmacokinetic studies to support marketing of immune globuline intravenous (human) as replacement therapy for primary humoral immunodeficiency
210  1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,$d[2008]
215   $ai, 15 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on Apr. 21, 2009).
300   $a"June 2008."
320   $aIncludes bibliographical references (pages 14-15).
517   $aGuidance for industry 
606   $aImmunoglobulins$xPharmacokinetics
606   $aImmunoglobulins$xMarketing
615  0$aImmunoglobulins$xPharmacokinetics.
615  0$aImmunoglobulins$xMarketing.
712 02$aCenter for Biologics Evaluation and Research (U.S.)
801  0$bGPO
801  1$bGPO
801  2$bGPO
906   $aBOOK
912   $a9910698731603321
996   $aGuidance for industry$93434577
997   $aUNINA