Thorough QT Study: Design Features for Consideration - IIR

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Slide 22 Time Points of Data Acquisition • Must reasonably account for individual variation in T max and possible hysteresis • The more time points, the greater potential for failing to demonstrate non-inferiority to placebo at a given time point due to the bias inherent in multiple comparisons • 3 time points around population T max and a trough (before a next administration) to account for metabolites may be reasonable
Slide 23 Protection Against Inflated Potential for False Finding of Drug Effect in Multiple Comparisons • Inconsistent with ICH-E14 guidelines Beasley, et al. (2005) J Am Coll Cardiol 46:678-87 Eaton, et al. (2006) Drug Inf J 40:267-271
Page 1 and 2: Slide 1 Thorough QT Study: Design F
Page 3 and 4: Slide 3 Ventricular Repolarization:
Page 5 and 6: Slide 5 Hierarchy of Desired Outcom
Page 7 and 8: Slide 7 “Stage 1” Outcome Diffe
Page 9 and 10: Slide 9 “Stage 3” Outcome Diffe
Page 11 and 12: Slide 11 Homogeneous vs Diverse Sub
Page 13 and 14: Number of Replicate ECGs Signal Ave
Page 15 and 16: Slide 15 Which Positive Control •
Page 17 and 18: Slide 17 Can Adequate Exposure to T
Page 19 and 20: Slide 19 Single Dose Design • Sin
Page 21: Slide 21 Multiple Administrations t
Page 25: Slide 25

Thorough QT Study: Design Features for Consideration - IIR

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