Abstract Details
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Activity Number:
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128
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Type:
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Contributed
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Date/Time:
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Monday, August 4, 2014 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #313116
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Title:
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Comparison Between Adaptive Designs for Bio-Equivalence Study
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Author(s):
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Shuai Yuan*+ and Fang Liu and Jialin Xu
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Companies:
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Merck and Merck and Merck
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Keywords:
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Bio-equivalence study ;
Group sequential design ;
Sample size reestimation ;
Power ;
Type-I error
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Abstract:
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Diane Potvin, et al (2008) studied four types of adaptive designs with sample size re-estimation and recommended one type of such design. In this report, except sample size reestimation method, we also consider group sequential method with the recommended operation characteristics (e.g. alpha-spending, testing procedure, and decision rules), add more stages, and permit stopping for futility. The simulations show that the modified group sequential design for BE study has more flexibility with desired type-I error and power.
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Authors who are presenting talks have a * after their name.
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