Legend: Palais des congrès de Montréal = CC, Le Westin Montréal = W, Intercontinental Montréal = I
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
Activity Details
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| 25 * | Sun, 8/4/2013, 2:00 PM - 3:50 PM | CC-512f | |
| Statistical Issues in Assessing Performance of Diagnostic Devices — Topic Contributed Papers | |||
| Section on Statistics in Epidemiology , Biopharmaceutical Section , ASA Special Interest Group for Medical Devices and Diagnostics | |||
| Organizer(s): Lakshmi Vishnuvajjala, FDA/CDRH Division of Biostatistics | |||
| Chair(s): Jeffrey L. Joseph, Theorem Clinical Research | |||
| 2:05 PM | Analytical and Clinical Validation of Diagnostic Devices with Underlying High-Dimensional Input Data — Zhiheng Xu, FDA ; Tinghui Yu, FDA/CDRH ; Meijuan Li, FDA/CDRH ; Lakshmi Vishnuvajjala, FDA/CDRH Division of Biostatistics | ||
| 2:25 PM | Noninferiority of Diagnostic Tests — Lakshmi Vishnuvajjala, FDA/CDRH Division of Biostatistics | ||
| 2:45 PM | Adjusting for Measurement Error in the Performance Evaluation of Diagnostic Medical Tests — Gene Pennello, Food and Drug Administration | ||
| 3:05 PM | The Effect of Precision at the Decision Point on Diagnostics Accuracy of a Biomarker Assay — Jeng Mah, Beckman Coulter, Inc. | ||
| 3:25 PM | Floor Discussion | ||
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