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Activity Number:
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384
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 6, 2008 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302434 |
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Title:
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Exploration of Covariance Structure for TQT Study
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Author(s):
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Xiaodong Li*+
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Companies:
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Merck & Co., Inc.
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Address:
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, , ,
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Keywords:
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TQT ; covariance ; Toeplitz ; compound symmetry ; AIC ; BIC
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Abstract:
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QT interval represents the time between the start of ventricular depolarization and the end of ventricular repolarization (QT). QTc is the QT-interval corrected for heart rates. QT prolongation is dangerous and may cause death in some cases.Current FDA ICH E 14 guidance requires all sponsors submitting new drug applications to conduct a thorough QT/QTc study to demonstrate the lack of QT prolongation effect for their drug.The primary endpoint is the time-matched mean difference between the drug and placebo after baseline adjustment at each time point. Paired t-tests are often used by regulatory agencies but a linear model may be more appropriate. The appropriate covariance structure for a linear model approach is still in debate. This talk will focus on the results of an analysis which shows similar patterns in the covariance matrices for different compounds.
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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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