01353nam 2200373Ia 450 991069895100332120090706144256.0(CKB)5470000002398366(OCoLC)422635611(EXLCZ)99547000000239836620090706d2001 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry[electronic resource] M4, organization of the CTDRockville, 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]7 pages digital, PDF fileTitle from PDF title page (viewed on July 6, 2009)."ICH"."August 2001".Guidance for industry Drug approvalGovernment policyUnited StatesDrug approvalGovernment policyCenter for Drug Evaluation and Research (U.S.)Center for Biologics Evaluation and Research (U.S.)International Conference on Harmonisation.GPOGPOBOOK9910698951003321Guidance for industry3434577UNINA