TABLE 1.
Parameter estimates for our final population pharmacokinetic modela
| Parameter | PK estimate from Monolix (RSE [%]) | CV (%) (RSE [%]) | Estimate from previous publication (24) using NPEM |
|---|---|---|---|
| Ka (h−1) | 4.8 | 29.8 (128) | 5.96 |
| V/F (liters) | 10.7 (32) | 81.21 | |
| Male | 79.1 (5) | ||
| Female | 49.4 (9) | ||
| CL/F (liters/h) | 6.22 (9) | 26.4 (23) | 7.63 |
| Residual variability | |||
| a | 0.0891 μg/ml (47) | ||
| b | 11.6% (11) |
a
All pharmacokinetic parameters are expressed as medians. RSE, relative standard error; CV, coefficient of variation. The Ka estimate was capped at 5; the RSE was not estimated for Ka. Log(CL/F) = log(6.22) + 0.0107 * (CLCR − 79.08) + 0.75 * [log(weight) − log(56 kg)]. Log(V/F) = log(79.1) − 0.472 * sex (female) + [log(weight) − log(56 kg)]; male was considered the reference population. For residual variability, a and b represent the constant and proportional parts of the residual variability, respectively.