Utility of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies: a viewpoint from the FDA

Diabetologia. 2023 Mar;66(3):603-604. doi: 10.1007/s00125-022-05853-9. Epub 2022 Dec 21.

¹ Division of Diabetes, Lipid Disorders, and Obesity, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. justin.penzenstadler@fda.hhs.gov.
² Division of Pharmacometrics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
³ Division of Diabetes, Lipid Disorders, and Obesity, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

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