Table 3.
Simulated AUC0–24h (h • mg/L) at day 14 after daily dosing, with only inter-individual variability (IIV) or with IIV + inter-occasion variability (IOV), as well as median individual deviation in simulated AUC0–24h (h • mg/L) between simulating with only IIV or with IIV + IOV.
Dose group | Median AUC0–24h (h • mg/L) (95% PI) | Median individual deviation (h • mg/L) (95% PI) | |
---|---|---|---|
IIV | IOV + IIV | ||
10 mg/kg | 39.9 (18.8 to 81.6) | 39.3 (16.4 to 93.6) | 0.6 (−40 to 48) |
20 mg/kg | 120.3 (68.0 to 230.5) | 123.5 (59.4 to 266.7) | 1.9 (−12 to 36) |
25 mg/kg | 151.4 (82.8 to 297.9) | 155.3 (72.5 to 348.4) | 2.7 (−152 to 181) |
30 mg/kg | 194.3 (107.2 to 382.3) | 202.6 (91.0 to 452.5) | 5.2 (−197 to 231) |
35 mg/kg | 248.7 (141.3 to 491.6) | 261.9 (118.9 to 586.7) | 7.7 (−260 to 305) |
In Figure 3 , the simulated AUC0–24h in 1,000 patients for a dose of 35 mg/kg at days 1, 7, and 14 is illustrated.
PI, prediction interval; IIV, inter-individual variability; IOV, inter-occasion variability.