01544nam 2200421Ia 450 991069895080332120090706152327.0(CKB)5470000002398368(OCoLC)422637158(EXLCZ)99547000000239836820090706d2001 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry[electronic resource] M4E, the CTD, efficacyRockville, 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]iii, 58 pages digital, PDF fileTitle from PDF title page (viewed on July 6, 2009)."ICH"."August 2001".Guidance for industry Drug approvalGovernment policyUnited StatesClinical trialsReportingUnited StatesDrugsEffectivenessUnited StatesDrug approvalGovernment policyClinical trialsReportingDrugsEffectivenessCenter for Drug Evaluation and Research (U.S.)Center for Biologics Evaluation and Research (U.S.)International Conference on Harmonisation.GPOGPOBOOK9910698950803321Guidance for industry3434577UNINA