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100   $a20091207d1995      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 04$aThe extent of population exposure to assess clinical safety$b[electronic resource] $efor drugs intended for long-term treatment of of non-life threatening conditions
210  1$a[Rockville, MD] :$c[U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research],$d[1995]
215   $a1 online resource (4 pages)
225 1 $aGuideline for industry ;$vICH-E1A
300   $a"March 1995."
410  0$aGuideline for industry ;$vICH - E1A.
517   $aExtent of population exposure to assess clinical safety 
606   $aDrugs$xDosage$zUnited States
606   $aDrugs$xSide effects$zUnited States
615  0$aDrugs$xDosage
615  0$aDrugs$xSide effects
712 02$aUnited States.$bFood and Drug Administration.
712 12$aInternational Conference on Harmonisation.
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910699268403321
996   $aThe extent of population exposure to assess clinical safety$93534308
997   $aUNINA