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Abstract Details

Activity Number: 167
Type: Topic Contributed
Date/Time: Monday, July 30, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #306399
Title: Concentration-QTc Modeling Approach
Author(s): Joanne Zhang*+
Companies: FDA/CDER
Address: 10903 New Hampshire Ave, Silver Spring, MD, , USA
Keywords: concentration-QTc modeling ; post-hoc

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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