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Activity Number:
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329
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Type:
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Roundtables
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Date/Time:
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Tuesday, August 4, 2009 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303348 |
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Title:
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Statistical Issues on Design and Analysis of Thorough QT Clinical Trials
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Author(s):
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Yi Tsong*+
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Companies:
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FDA
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Address:
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CDER, 10903 New Hampshire Ave, Silver Spring, MD, 20993,
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Keywords:
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thorough QT study ; QT correction ; multiple comparisons ; validation test ; hybrid designs
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Abstract:
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In order to assess the potential cardiac risk of a new test drug product, ICH issued a guidance on design and analysis of thorough QT studies in 2005. In the last 3 years after the publication, researchers and regulatory reviewers encountered many issues on the design and analysis of thorough QT clinical trials that were not anticipated at the stage of design. The objective of this roundtable is to share the experiences and discuss the issues and potential solutions.
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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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