Abstract Details
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Activity Number:
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519
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 7, 2013 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #310423 |
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Title:
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Statistical Considerations for Bridging/Multi-Regional Trials
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Author(s):
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Shein-Chung Chow*+
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Companies:
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Duke University
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Keywords:
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MRCT ;
bridging study ;
ICH
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Abstract:
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In 1998, the International Conference on Harmonization (ICH) issued a guideline on Ethnic Factors in the Acceptability of Foreign Clinical Data to determine if clinical data generated from the original region are acceptable in a new region. The purpose of this guideline is not only to permit adequate evaluation of the influence of ethnic factors on clinical efficacy and safety of the approved test treatment (at the original region) for regulatory review/approval in the new region, but also to minimize duplication of clinical studies and consequently not to delay the availability of the approved test treatment in the new region. In this presentation, some practical issues that are commonly encountered when conducting bridging/multi-regional studies are discussed. These practical issues include criteria for assessment of similarity between regions and sample size calculation/allocation for bridging/multi-regional studies.
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Authors who are presenting talks have a * after their name.
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