This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
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Activity Number:
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117
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 2, 2010 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #307409 |
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Title:
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Evaluation of Multiregional Clinical Trials: Statistical and Other Issues in Each Development Stage
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Author(s):
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Yuki Ando*+
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Companies:
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Pharmaceuticals and Medical Devices Agency
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Address:
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3-3-2, Kasumigaseki, Chiyodaku, Tokyo, International, 100-0013, JAPAN
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Keywords:
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ethnic difference ;
consistency ;
dose response
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Abstract:
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In Japan, the number of multi-regional clinical trials (MRCTs) conducted for the purpose of faster and globally simultaneous new drug submission is still increasing. Recently MRCTs in earlier drug development stages are actively planned; however most MRCTs were phase III confirmatory trials just after guidance document "Basic Principles on Global Clinical Trials" was issued in Sep. 2007. There are several new drugs that already approved with MRCTs in Japan. We expect that more new drug applications will be submitted with various types of clinical data packages in the near future. In this presentation, recent statistical and other issues corresponding to multi-regional clinical trials in each development stage will be reviewed on the basis of Japanese review experience.
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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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