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Practical Issues to Consider: Design and Analysis of Thorough QT/QTc Study

Practical Issues to Consider: Design and Analysis of Thorough QT/QTc Study. Venkat Sethuraman FDA/Industry Workshop, 14-16 Sept., 2005. Outline. Introduction ICH E14; QT correction methods Study Design Considerations Choice of Baseline; positive control; # of ECG replicates

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Practical Issues to Consider: Design and Analysis of Thorough QT/QTc Study