LEADER 01611oam  2200433 a 450 
001 9910702187003321
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035   $a(CKB)5470000002424265
035   $a(OCoLC)400009435
035   $a(EXLCZ)995470000002424265
100   $a20090615d2005      ua             0
101 0 $aeng
135   $aurbn|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $eQ5E comparability of biotechnological/biological products subject to changes in their manufacturing process
210  1$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[2005]
215   $a1 online resource (14 pages)
300   $aTitle from title screen (viewed on June 16, 2009).
300   $a"ICH".
300   $a"June 2005".
320   $aIncludes bibliographical references (page 14).
517   $aGuidance for industry 
606   $aBiotechnological process monitoring
606   $aPharmaceutical biotechnology
606   $aBiological products
615  0$aBiotechnological process monitoring.
615  0$aPharmaceutical biotechnology.
615  0$aBiological products.
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
801  2$bGPO
906   $aBOOK
912   $a9910702187003321
996   $aGuidance for industry$93434577
997   $aUNINA