This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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627
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Type:
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Contributed
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Date/Time:
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Thursday, August 5, 2010 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #307434 |
Title:
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Considerations on the Study Design and Analysis of Vulvar and Vaginal Atrophy Studies
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Author(s):
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Ling Chen*+
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Companies:
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FDA
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Address:
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10903 New Hampshire Ave., Silver Spring, MD, 20903,
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Keywords:
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Association ;
Clinical trial ;
Drug efficacy ;
Estrogen therapies ;
Vulvar and Vaginal Atrophy
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Abstract:
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One of the 2008 research projects supported by CDER's Regulatory Science Review Enhancement Program was to study how vulvar and vaginal atrophy (VVA) symptoms are associated, and to provide meaningful information on improving the study design and data analysis of the VVA studies. The associations among the VVA symptoms at baseline of the study for the VVA indication provide clinically meaningful information about vulvovaginal atrophy, and the associations among VVA symptoms at the end of the study (Week 12) are directly related to drug efficacy. This presentation will report the research findings, and make several recommendations on the design of the VVA studies, and on the statistical methodology used for evaluating drug efficacy of the VVA indication.
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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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