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Abstract Details
Activity Number:
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100
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Type:
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Invited
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Date/Time:
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Monday, July 30, 2012 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #303897 |
Title:
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A Case Study for Selection of Margin and Statistical Analysis Method
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Author(s):
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Bo Yang*+
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Companies:
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Merck Research Laboratories
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Address:
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2015 Galloping Hill Rd, Kenilworth, NJ, 07920,
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Keywords:
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Abstract:
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Recently, FDA issued a guidance about design and analysis of non-inferiority study. This guidance provides answers to many frequently encountered issues in the design of NI trials. However, questions remain that continue to challenge the design and analysis of well controlled and well powered NI clinical trials. In this talk, a case study for selection of non-inferiority margin and analysis method is presented to illustrate current statistical, clinical and regulatory issues and challenges.
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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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