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001 9910698975303321
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035   $a(CKB)5470000002398120
035   $a(OCoLC)404070022
035   $a(EXLCZ)995470000002398120
100   $a20090619d2004      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $eaddendum to E2C clinical safety data management : periodic safety update reports for marketed drugs
210  1$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[2004]
215   $a9 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on June 19, 2009).
300   $a"ICH".
300   $a"February 2004".
517   $aGuidance for industry 
606   $aClinical pharmacology
606   $aDrugs$xSide effects$xReporting
606   $aDrugs$xTesting
615  0$aClinical pharmacology.
615  0$aDrugs$xSide effects$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   $a9910698975303321
996   $aGuidance for industry$93434577
997   $aUNINA