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Abstract Details
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Activity Number:
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650
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 2, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304722 |
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Title:
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Decision Rules and Associated Sample Size Planning for Regional Approval Utilizing Multiregional Clinical Trials
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Author(s):
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Nelson Lu*+ and Rajesh Nair and Yunling Xu
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Companies:
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FDA and FDA and FDA
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Address:
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10903 New Hampshire Ave., Silver Spring, MD, , USA
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Keywords:
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Multiregional clinical trial ;
Decision rule ;
Sample size planning
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Abstract:
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Multiregional clinical trials provide the potential to make safe and effective medical products simultaneously available to patients globally. As regulatory decisions are always made in a local context, this poses huge regulatory challenges. In this paper we propose two conditional decision rules which can be used for medical product approval by local regulatory agencies based on the results of a multiregional clinical trial. We also illustrate sample size planning for such trials.
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