01521nam 2200421Ia 450 991069692330332120230902161803.0(CKB)5470000002383662(OCoLC)558588044(EXLCZ)99547000000238366220100318d2009 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry[electronic resource] assay development for immunogenicity testing of therapeutic proteinsRockville, 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Evaluation and Research :Center for Biologics Evaluation and Research,[2009]1 online resource (20 pages) illustrations"Draft guidance.""CMC.""December 2009."Includes bibliographical references (pages 19-20).Guidance for industry ImmunogeneticsUnited StatesBiological assayProteinsTherapeutic useTestingImmunogeneticsBiological assay.ProteinsTherapeutic useTesting.Center for Drug Evaluation and Research (U.S.)Center for Biologics Evaluation and Research (U.S.)GPOGPOBOOK9910696923303321Guidance for industry3434577UNINA