JSM 2011 Online Program

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Activity Details


66 * Sun, 7/31/2011, 4:00 PM - 5:50 PM CC-D237
Evaluation of Monitoring, Diagnostic, and Placement Guidance Devices — Topic Contributed Papers
Biopharmaceutical Section , Section on Statistics in Epidemiology
Organizer(s): Meijuan Li, U.S. Food and Drug Administration/CDRH, Vandana Mukhi, U.S. Food and Drug Administration/CDRH
Chair(s): Estelle Russek-Cohen, U.S. Food and Drug Administration
4:05 PM Design of Cross-Sectional Method Comparison Studies Farzad Noubary, Massachusetts General Hospital ; Michael Hughes, Harvard School of Public Health
4:25 PM A Comparison Model for Measuring Individual Agreement Yuqing Tang, U.S. Food and Drug Administration ; Lawrence Lin, Baxter Healthcare Corporation ; Samad Hedayat, University of Illinois at Chicago
4:45 PM Statistical Design and Analysis Issues for Monitoring Devices Shanti Gomatam, U.S. Food and Drug Administration/CDRH
5:05 PM Evaluation of Placement Guidance Devices
5:25 PM Statistical and Regulatory Issues Associated with Biomarker Evaluation in Monitoring Studies Kyunghee Kim Song, U.S. Food and Drug Administration/CDRH
5:45 PM Floor Discussion



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