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035   $a(EXLCZ)995470000002398104
100   $a20090618d2005      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aRevision of the ICH guideline on clinical safety data management$b[electronic resource] $edata elements for transmission of individual case safety reports
210  1$a[Rockville, MD] :$c[Center for Drug Evaluation and Research]:$c[Center for Biologics Evaluation and Research],$d[2005]
215   $a25 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on June 18, 2009).
300   $a"ICH harmonised tripartite guideline".
300   $a"Version 2.0".
300   $a"12 May 2005".
517   $aRevision of the ICH guideline on clinical safety data management 
606   $aClinical pharmacology
606   $aClinical trials$xReporting
606   $aDrugs$xTesting
615  0$aClinical pharmacology.
615  0$aClinical trials$xReporting.
615  0$aDrugs$xTesting.
712 02$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   $a9910698976903321
996   $aRevision of the ICH guideline on clinical safety data management$93448817
997   $aUNINA