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Activity Number:
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274
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, July 31, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308428 |
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Title:
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Effect of Baseline Measurement on the Change from Baseline in QTc Intervals
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Author(s):
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Hong Tian*+ and Jaya Natarajan
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Companies:
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Johnson & Johnson PRD and Johnson & Johnson PRD
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Address:
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1000 Route 202, Raritan, NJ, 08869,
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Keywords:
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QTc intervals ; Baseline ; Change from baseline ; Parallel group designs
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Abstract:
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Phase I thorough QT (TQT) studies are routinely conducted by pharmaceutical companies for all new compounds to satisfy the requirements of ICH E14 guidance on the evaluation of QTc prolongation. The primary endpoint is the change from baseline in QTc and the hypothesis of interest is the non-inferiority of drug to placebo. Sometimes, due to the properties of the compound, it becomes necessary to use parallel group designs for TQT studies. In such situations, the effect of the baseline on the change from baseline in QTc becomes an important issue since differing baseline between the drug and placebo groups may not allow for proper estimation of the drug's effect. In this work, we evaluate the effect of baseline on the change from baseline using the placebo data from several TQT studies. Resampling techniques are used to evaluate the impact of differing baselines across groups.
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