Table 3.
Final parameter estimates from the population pharmacokinetic model with allometric scaling by fat-free mass
| Parameter | Estimate (relative SE [%]) | % between-subject variability (relative SE [%]) |
|---|---|---|
| Absorption rate (ka) (h−1) | 0.416 (11.5) | 18.2 (115.5) |
| Clearance (CL/F) (liters/day/53 kg FFMa) | 3.99 (3.5)c | 32.1 (18.4) |
| Volume of central compartment (V2/F) (liters/53 kg FFM) | 40.1 (4.5)c | 34.1 (27.3) |
| Intercompartmental clearance (Q/F) (liters/day) | 0.0347 (18.3) | NEb |
| Volume of peripheral compartment (V3/F) (liters) | 1.75 (8.2) | NE |
| Residual variability, Pediatric Indian study (%) | 54.5 (5.5) | NE |
| Residual variability, Adult Indian study (%) | 34.3 (3.7) | NE |
| Residual variability, Adult European study (%) | 34.8 (6.9) | NE |
a
FFM, fat-free mass.
b
NE, not estimated.
c
Estimate is given for a standardized fat-free mass of 53 kg. Between-subject variabilities in CL/F and V2/F correlated with a correlation coefficient of 0.92.