01490nam 2200397Ia 450 991069894860332120090707145610.0(CKB)5470000002398390(OCoLC)422762939(EXLCZ)99547000000239839020090707d2001 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry[electronic resource] M4S, the CTD, safetyRockville, MD :U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :Center for Biologics Evaluation and Research,[2001]ii, 21 pages digital, PDF fileTitle from PDF title page (viewed on July 7, 2009)."ICH"."August 2001".Guidance for industry Drug approvalGovernment policyUnited StatesClinical trialsReportingGovernment policyUnited StatesDrug approvalGovernment policyClinical trialsReportingGovernment policyCenter for Drug Evaluation and Research (U.S.)Center for Biologics Evaluation and Research (U.S.)International Conference on Harmonisation.GPOGPOBOOK9910698948603321Guidance for industry3434577UNINA