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Abstract Details
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Activity Number:
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66
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Type:
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Topic Contributed
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Date/Time:
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Sunday, July 31, 2011 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302186 |
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Title:
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Statistical Design and Analysis Issues for Monitoring Devices
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Author(s):
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Shanti Gomatam*+
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Companies:
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U.S. Food and Drug Administration/CDRH
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Address:
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10903 New Hampshire Avenue (FDA), Silver Spring, 20993-0002,
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Keywords:
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diagnostic devices
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Abstract:
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The design of studies and assessment of performance for devices that monitor patient clinical parameters or conditions have specific challenges. This work discusses different types of monitoring devices and the associated statistical design and analysis challenges.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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