For validation of the predictive performance following administration of sublingual solution, seven PK studies, spanning a dose range of 2–16 mg and including a total of 75 subjects (aged 21 to 42) with 81 concentration-time profiles, were used (Table 4) [25, 27, 41, 50]. For all seven PK studies, the P/O ratios of AUC, CL/F, and Tmax fell within the 2-fold prediction error range. The P/O ratio for Cmax fell within the 2-fold prediction error range in six out of seven (85.7%) PK studies. Geometric mean (95% CI) AUC, CL/F, Cmax, and Tmax P/O ratios were 1.05 (0.75–1.46), 0.98 (0.72–1.33), 1.34 (0.95–1.90), and 1.06 (0.79–1.41), respectively.