Table 3.

Pediatric physiologically based pharmacokinetic model-predicted versus observed AUC 0-τ^a

Study	5-mg/kg/day target dose	10-mg/kg/day target dose	20-mg/kg/day target dose
Day 1 at 1.25 mg/kg
Devinsky et al. [13]	70.6 (20.4) (N = 10)	66.4 (121) (N = 8)	73.7 (96.6) (N = 9)
This study	76.5 (59.4)	76.5 (59.4)	76.5 (59.4)
Day 22 at target dose via BID
Devinsky et al. [13]	241 (101) (N = 10)	722 (79.9) (N = 8)	963 (93.4) (N = 9)
This study	207 (64.6)	401 (60.0)	748 (57.3)

AUC area under the curve, BID twice daily, N number of patients

^aτ: 5 hours, ${\mathrm{A}\mathrm{U}\mathrm{C}}_{0-\mathrm{\tau }}$ presented as a geometric mean in ng⋅h/mL (% coefficient of variation)