Table 1 Population estimates for the first pediatric PopPK model of rivaroxaban
Parameter | Mean estimate | Relative standard error (%)a | Inter-individual variability CV (%)b | Relative standard error (%)† | Description |
|---|---|---|---|---|---|
ka for tablet and diluted suspension (1 h− 1) | 0.717 | 21.3 | 39.7 | 63.9 | Absorption rate constant |
ka for undiluted suspension (1 h−1) | 0.208 | 15.4 | |||
CL (l h−1) | 7.26 | 9.38 | 26.2 | 39.2 | Clearance for a subject with a body weight of 70 kg |
V (l) | 50.9 | 12 | N/A | N/A | Volume of distribution in the central compartment for a subject with a body weight of 70 kg |
Q (l h− 1) | 0.928 | 17.5 | N/A | N/A | Intercompartmental clearance |
Vp (l) | 13.5 | 51.5 | N/A | N/A | Volume of distribution in the peripheral compartment |
Exponent for CL scaling | 0.323 | 27.1 | – | – | Exponent to scale CL on the individual body weight |
Exponent for V scaling | 1 | Fixed | – | – | Exponent to scale V on the individual body weight |
F1 | 0.648 | 9.03 | N/A | N/A | Relative bioavailability for the rivaroxaban 20 mg-equivalent doses in relation to the rivaroxaban 10 mg-equivalent doses with F1 = 1 per definition |
Residual error (%) | 46.6 | 14.1 | – | – | Proportional residual error |