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648 * ! Thu, 8/2/2012, 10:30 AM - 12:20 PM CC-Room 24A
Missing Data, Agreement, and Method-Comparison Studies of Medical Devices and Diagnostics — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Jingjing Ye, FDA
Chair(s): Jingjing Ye, FDA
10:35 AM Improved Confidence Intervals for the Difference of Paired Binomials in Presence of Unpaired Data Vivek Pradhan, Boston Scientific Corporation ; Yun Lu, Boston Scientific Corporation
10:55 AM A Bayesian Approach to Handle Missing Data in Evaluation of Diagnostic Medical Devices Qin Li, FDA ; Gene Pennello, FDA
11:15 AM Study Design Issues and Statistical Challenges in Personalized Medicine Bridging Studies Meijuan Li, FDA/CDRH
11:35 AM Some Issues in Method Comparison Studies for Diagnostic Medical Devices Shanti Gomatam, FDA
11:55 AM Floor Discussion



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