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001 9910698950803321
005 20090706152327.0
035   $a(CKB)5470000002398368
035   $a(OCoLC)422637158
035   $a(EXLCZ)995470000002398368
100   $a20090706d2001      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $eM4E, the CTD, efficacy
210  1$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[2001]
215   $aiii, 58 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on July 6, 2009).
300   $a"ICH".
300   $a"August 2001".
517   $aGuidance for industry 
606   $aDrug approval$xGovernment policy$zUnited States
606   $aClinical trials$xReporting$zUnited States
606   $aDrugs$xEffectiveness$zUnited States
615  0$aDrug approval$xGovernment policy
615  0$aClinical trials$xReporting
615  0$aDrugs$xEffectiveness
712 02$aCenter for Drug Evaluation and Research (U.S.)
712 02$aCenter for Biologics Evaluation and Research (U.S.)
712 12$aInternational Conference on Harmonisation.
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910698950803321
996   $aGuidance for industry$93434577
997   $aUNINA