Table 3.
Estimated pharmacokinetic parameters for all patients included in the final BAY 94-9027 population pharmacokinetic model
| Parameter | < 6 years (n = 25) | 6 to < 12 years (n = 28) | 12 to < 18 years (n = 12) | ≥ 18 years (n = 133) | All (N = 198) |
|---|---|---|---|---|---|
| AUCstand (IU·h/dL) | 2159 (27.3) | 2717 (22.4) | 3441 (34.2) | 4052 (31.1) | 3501 (38.3) |
| t½ (h) | 13.1 (21.0) | 15.1 (19.4) | 16.8 (25.2) | 17.4 (28.8) | 16.4 (28.3) |
| CL (dL·h/kg) | 0.0278 (27.3) | 0.0221 (22.4) | 0.0174 (34.2) | 0.0148 (31.1) | 0.0171 (38.3) |
| Vss (dL/kg) | 0.524 (11.6) | 0.481 (14.5) | 0.423 (15.5) | 0.373 (15.6) | 0.406 (20.0) |
Data are geometric mean (% CV) and based on chromogenic assay data using a 60 IU/kg dose
AUC area under the curve, stand standardized, CL clearance, CV coefficient of variance, t½ half-life, Vss steady-state volume of distribution