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035   $a(OCoLC)404100715
035   $a(EXLCZ)995470000002398123
100   $a20090619d2003      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aPost-approval safety data management$b[electronic resource] $edefinitions and standards for expedited reporting
210  1$a[Rockville, Md.?] :$c[U.S. Dept. of Health and Human Services, Food and Drug Administration],$d[2003]
215   $a12 $cdigital, PDF file
300   $aTitle from PDF title page (viewed on June 19, 2009).
300   $a"ICH harmonised tripartite guideline draft".
300   $a"Recommended for adoption at step 2 of the ICH process on July 19, 2003 by the ICH Steering Committee".
300   $a"ICH E2E ver. 3.8".
517   $aPost-approval safety data management 
606   $aDrugs$xSide effects$xReporting
606   $aClinical pharmacology
615  0$aDrugs$xSide effects$xReporting.
615  0$aClinical pharmacology.
712 02$aUnited States.$bFood and Drug Administration.
712 12$aInternational Conference on Harmonisation.
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910698975003321
996   $aPost-approval safety data management$93530385
997   $aUNINA