The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
Abstract Details
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Activity Number:
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501
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 3, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #300922 |
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Title:
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Stratified Analysis of Bioequivalence and Therapeutic Equivalence Trials Data When the Metric Is Ratio of Parameters
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Author(s):
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Kallappa M. Koti*+
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Companies:
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U.S. Food and Drug Administration
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Address:
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10903 New Hampshire Avenue, Silver Spring, MD, 20993,
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Keywords:
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Non-inferiority ;
non-unity ratio hypothesis ;
Fieller-Hinkley Distribution ;
IUT test ;
generic medicines ;
bio-similar products.
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Abstract:
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Testing for equivalence in terms of the ratio of the parameters is often preferred rather than the difference. Fieller's method, which is often used to prove or disprove equivalence, does not always work. We propose some simpler new methods for demonstrating bioequivalence and therapeutic equivalence when the metric is a ratio of parameters and the margin is prespecified. We focus on stratified analysis. We consider comparison of means, binomial proportions, and medians of time to event endpoints. The views expressed in this presentation do not necessarily reflect those of the Food and Drug Administration.
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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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