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Abstract Details
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Activity Number:
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530
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Type:
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Roundtables
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Date/Time:
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Wednesday, August 1, 2012 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #306219 |
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Title:
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Evaluation of Sex Differences in Clinical Studies
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Author(s):
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Chul Ahn*+
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Companies:
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FDA/CDRH
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Address:
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10903 New Hampshire Avenue, Silver Spring, MD, 20993, United States
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Keywords:
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Abstract:
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The CDRH draft guidance on sex differences in medical device trials is officially out as of December 19, 2011. In this roundtable we will discuss issues regarding the underrepresentation of women in clinical trials and the recommended statistical analyses of study data for sex differences including strategies of allocating alpha.
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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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