Estimation of the Power of the Food Effect on QTc to Show Assay Sensitivity

Figures

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  Figure 1. Performance of assay sensitivity as a function of the number of subjects included.

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  Figure 2. Influence of the choice of reference for the power to show assay sensitivity. Data from study 3 only.

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  Figure 3. Percent of simulated studies based on study 3, in which a significant decrease was detected 3 or 4 hours after drug administration, that is, in a fasted state, compared with predose.

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  Figure 4. Distribution of the estimated change from preprandial baseline for the simulations based on the 3 studies. Each column presents 1 study, the panels giving the 2 postprandial times considered. Each box‐and‐whiskers element gives the distribution of the change of QTcF from the preprandial reference across the simulated studies with the respective sample size per group. The y axis gives predicted ΔQTcF of food effect in milliseconds. The tick on the right y axis represents the model‐based effect.

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  Figure 5. Power to detect assay sensitivity by size of simulated drug effect for various sample sizes. Each line gives the power, that is, the percentage of studies in which assay sensitivity could be shown for a different sample size over a range of simulated drug effects.