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035   $a(OCoLC)558594862
035   $a(EXLCZ)995470000002383660
100   $a20100318d2000      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $eanalytical procedures and methods validation, chemistry, manufacturing, and controls documentation
210  1$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[2000]
215   $a1 online resource (33 pages)
300   $a"Draft guidance."
300   $a"CMC #."
300   $a"August 2000."
320   $aIncludes bibliographical references (pages 30-31).
517   $aGuidance for industry 
606   $aDrugs$xTesting$xDocumentation$zUnited States
615  0$aDrugs$xTesting$xDocumentation
712 02$aCenter for Drug Evaluation and Research (U.S.)
712 02$aCenter for Biologics Evaluation and Research (U.S.)
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910696923503321
996   $aGuidance for industry$93434577
997   $aUNINA