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Session 2 - Diabetic Drug Development and CV Safety
Session Chair(s)
Philip T. Sager, MD
Adjunct Professor
Stanford University, United States
DIABETIC DRUG DEVELOPMENT AND CV SAFETY
Speaker(s)
FDA – GUIDANCE FOR INDUSTRY – EVALUATING CARDIOVASCULAR RISK OF NEW ANTIDIABETIC THERAPIES
Mary Parks, MD
FDA, United States
Director, Div. of Endocrinology and Metabolism Prod., ODE II, CDER
FDA – GUIDANCE FOR INDUSTRY – EVALUATING CARDIOVASCULAR RISK OF NEW ANTIDIABETIC THERAPIES
Hylton Joffe, MD
FDA, United States
Director, Office of Cardiology, Hematology, Endocrinology Nephrology,
POWER CALCULATIONS AND INFERIORITY MARGIN ISSUES IN DESIGNING CV RISK ASSESSMENT STUDIES IN T2DM (INCLUDING THOUGHTS ON NOVEL STATISTICAL APPROACHES)
Thomas R. Fleming, PhD, MA
University of Washington, United States
Professor of Biostatistics
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