Figure 4.
E-R relationship obtained from phase II and phase III trials. Data points are mean effects with 95% CI for quantiles of AUC values and the line represents the estimated E-R relationship. The vertical lines with diamonds along the abscissa represent medians and 90% exposure ranges at each dose level. Data were a simulated phase IIb trial including 60 subjects at each dose level 30, 60, 120, 240 mg, or placebo, and a simulated phase III trial randomizing 160:160:320 subjects to placebo, 180 mg, or 240 mg.