01585nam 2200445Ia 450 991069897640332120090619121101.0(CKB)5470000002398109(OCoLC)403948199(EXLCZ)99547000000239810920090619d2005 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry[electronic resource] E2B(M), data elements for transmission of individual case study reports, questions and answersRockville, 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,[2005]17 pages digital, PDF fileTitle from PDF title page (viewed on June 19, 2009)."ICH"."March 2005"."Revision 2".Guidance for industry Clinical pharmacologyClinical trialsReportingDrugsTestingClinical pharmacology.Clinical trialsReporting.DrugsTesting.Center for Drug Evaluation and Research (U.S.)Center for Biologics Evaluation and Research (U.S.)International Conference on Harmonisation.GPOGPOGPOBOOK9910698976403321Guidance for industry3434577UNINA