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Abstract Details
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Activity Number:
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167
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 30, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #306399 |
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Title:
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Concentration-QTc Modeling Approach
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Author(s):
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Joanne Zhang*+
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Companies:
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FDA/CDER
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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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concentration-QTc modeling ;
post-hoc
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Abstract:
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As an exploratory tool to support the primary ICH E14 analysis of TQT studies, Concentration-QTc modeling has been used in almost every thorough QTc study (TQTS). This post-hoc analysis can be very useful for decision-making during the drug development. However, this approach also has its limitations. In this presentation, several statistical issues will be addressed, including the goodness-fit of the model, the observed relationship between QTc interval and the plasma concentration, and the challenge to find a proper Concentration-QTc model when there is a hysteresis. Finally, a proper setting of this approach in early phase might help to decide whether a TQTS is needed.
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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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