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Abstract Details
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Activity Number:
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68
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Type:
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Topic Contributed
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Date/Time:
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Sunday, July 31, 2011 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302963 |
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Title:
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Issues in Heart Rate Corrections for TQT Studies
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Author(s):
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Qianyu Dang*+ and Joanne Zhang
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Companies:
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U.S. Food and Drug Administration and U.S. Food and Drug Administration/CDER
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Address:
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11903 New Hampshire Ave, Silver Spring, MD, 20903, USA
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Keywords:
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QT Prolongation ;
Regression model ;
QT-RR correction
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Abstract:
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QT interval is well known to be correlated with heart rate. So in order to compare QT interval changes, the interval has to be corrected by heart rate in the analysis of TQT study data. Currently, there are one step correction methods using regression models and two step correction methods using fixed and data-driven corrections. In this research, we looked into the correction issue using real TQT data submitted to FDA as well as numerical simulations, especially when the heart rate was affected by the testing drug. We compared the potential bias in both point and interval estimations caused by several correcting methods in parallel and cross-over study design.
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Authors who are presenting talks have a * after their name.
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