LEADER 01501nam  2200397Ia 450 
001 9910698948403321
005 20090707152941.0
035   $a(CKB)5470000002398392
035   $a(OCoLC)422763158
035   $a(EXLCZ)995470000002398392
100   $a20090707d2001      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $eM4S, the CTD, safety appendices
210  1$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   $apages 21-115 $cdigital, PDF file
300   $aTitle from PDF title page (viewed on July 7, 2009).
300   $a"ICH".
300   $a"August 2001".
517   $aGuidance for industry 
606   $aDrug approval$xGovernment policy$zUnited States
606   $aClinical trials$xReporting$xGovernment policy$zUnited States
615  0$aDrug approval$xGovernment policy
615  0$aClinical trials$xReporting$xGovernment policy
712 02$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   $a9910698948403321
996   $aGuidance for industry$93434577
997   $aUNINA