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035   $a(CKB)5470000002383742
035   $a(OCoLC)565949861
035   $a(EXLCZ)995470000002383742
100   $a20100322d2003      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $eINDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls information
210  1$a[Rockville, MD] :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,$d[2003]
215   $a1 electronic resource (24 pages)
300   $a"CMC."
300   $a"May 2003."
320   $aIncludes bibliographical references (pages 23-24).
517   $aGuidance for industry 
606   $aMedicine, Experimental$xGovernment policy$zUnited States
606   $aDrug approval$zUnited States
615  0$aMedicine, Experimental$xGovernment policy
615  0$aDrug approval
712 02$aCenter for Drug Evaluation and Research (U.S.)
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910696915403321
996   $aGuidance for industry$93434577
997   $aUNINA