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Characterization of Proteomic Pharmacodynamic Biomarkers of IFNβ-1a Biologics to Inform Potential Utility in Biosimilar Development.

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第一作者： Lakshmi Manasa S,Chekka

第一单位： Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

作者： Lakshmi Manasa S,Chekka ^[1] ; Deepti P,Samarth ^[1] ; Yan,Guo ^[1] ; Esraa G,Mohamed ^[1] ; Erica,Decker ^[1] ; Murali K,Matta ^[1] ; Qin,Sun ^[2] ; William,Wheeler ^[3] ; Carlos,Sanabria ^[4] ; Joel,Wommack ^[5] ; Joseph,Gogain ^[5] ; Sarah J,Schrieber ^[6] ; Jeffry,Florian ^[1] ; Yow-Ming,Wang ^[2] ; David G,Strauss ^[1] ; Paula L,Hyland ^[1]

作者单位： Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA. ^[1] Therapeutic Biologics Program, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA. ^[2] Information Management Services, Inc, Rockville, Maryland, USA. ^[3] Spaulding Clinical Research, West Bend, Wisconsin, USA. ^[4] Standard BioTools, Inc, Boulder, Colorado, USA. ^[5] Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA. ^[6]