TABLE 5.
Overall summary of estimated voriconazole exposure parameters in Japanese pediatric subjects (current model) compared to non-Japanese pediatric subjects (original model)
| Parameter | Value [geometric mean (CV%)]a |
|||
|---|---|---|---|---|
| 8 mg/kg i.v. q12h |
9 mg/kg p.o. q12h (maximum, 350 mg) |
|||
| Non-Japaneseb | Japanesec | Non-Japaneseb | Japanesec | |
| AUC12 (μg · h/ml) | 29.2 (99) | 60.3 (55) | 15.7 (113) | 47.8 (67) |
| Cmax (μg/ml) | 4.90 (64) | 7.83 (37) | 2.67 (72) | 6.21 (51) |
| Cmin (μg/ml) | 1.04 (140) | 3.12 (79) | 0.480 (175) | 2.98 (78) |
| F1 (%) | 64d | 73 (17–99)e | ||
The summary statistics were based on the PK parameters calculated from the simulated concentrations using individual PK parameters and an infusion rate of 3 mg/kg/h for i.v. administration.
Based on pooled data from 40 non-Japanese children, 8 young adolescents weighing <50 kg, using the original integrated population PK model (6).
Based on 18 Japanese children and young adolescents weighing <50 kg using the current final model. For the p.o. regimen, n = 17.
Parameter estimates in children and adolescents from the original integrated population PK model (6). The variability in F was Manly transformed (11). ETATR = {[exp(ηF1)]0.367 − 1}/0.367; logit(F1,i) = logit(F1) + ETATR. The SD of ηF1 was estimated to be 1.67.
Arithmetic mean (range).