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Abstract Details
Activity Number:
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116
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 1, 2011 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #301654 |
Title:
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Noninferiority Testing with a Variable Margin
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Author(s):
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Yonghong Gao*+
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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 Ave., Silver Spring, MD, 20993,
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Keywords:
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Non-inferiority ;
variable margin ;
baseline covariates
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Abstract:
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The determination of non-inferiority margin is important in non-inferiority testing and the value of the margin is usually derived from historical data. If the margin depends on some baseline covariates, and the current active control population differs from the population used in historical trial in subject baseline covariates, namely violating the constancy assumption, then the non-inferiority margin is a variable margin. In this talk we will look at some analysis approaches to conduct non-inferiority testing under the covariate dependent margin.
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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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