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Abstract Details
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Activity Number:
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531
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Type:
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Roundtables
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Date/Time:
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Wednesday, August 3, 2011 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302576 |
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Title:
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Current Issues in the Design and Analysis of Noninferiority Trials
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Author(s):
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Gang Li*+
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Companies:
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Johnson & Johnson Pharmaceutical R&D, LLC
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Address:
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920 US Highway 202 S, Raritan, NJ, 08869,
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Keywords:
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Inferiority index ;
non-inferiority margin ;
bioequivalence ;
biosimilarity
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Abstract:
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Despite the release in 2010 of an FDA draft guidance on non-inferiority trials, controversies still exist. Perhaps the most difficult issue in designing non-inferiority trials has been specification of the non-inferiority margin, particularly when there's insufficient historical placebo-controlled information. The subjectivity of the currently used approaches for margin specification is also a source of the controversies. This session is to provide a platform for further dialogue on non-inferiority trials, including a new approach for margin specification.
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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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