01501nam 2200397Ia 450 991069894840332120090707152941.0(CKB)5470000002398392(OCoLC)422763158(EXLCZ)99547000000239839220090707d2001 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry[electronic resource] M4S, the CTD, safety appendicesRockville, 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]pages 21-115 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.GPOGPOBOOK9910698948403321Guidance for industry3434577UNINA