Thorough QT Study: Design Features for Consideration - IIR
Thorough QT Study: Design Features for Consideration - IIR
Thorough QT Study: Design Features for Consideration - IIR
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Slide 22<br />
Time Points of Data Acquisition<br />
• Must reasonably account <strong>for</strong> individual variation in T max and<br />
possible hysteresis<br />
• The more time points, the greater potential <strong>for</strong> failing to<br />
demonstrate non-inferiority to placebo at a given time point due to<br />
the bias inherent in multiple comparisons<br />
• 3 time points around population T max and a trough (be<strong>for</strong>e a next<br />
administration) to account <strong>for</strong> metabolites may be reasonable
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