Table 3.
Parameter Estimates of the Final Model with Allometric Scaling of Clearance and Volume of Distribution by Total Body Weight, Based on the Average Body Weight in the Study Population (43.7 kg)
| Parameter | Unit | Population Estimate or Median | Standard Error of the Population Estimate | IIV or Range | Eta Shrinkage |
|---|---|---|---|---|---|
| CL | L/h | 18.2 | 35% | 18% | 49% |
| V | L | 167 | 38% | 33% | 37% |
| F | - | 0.76 | - | 0.20 – 0.91 | 54% |
| ka | h−1 | 2.21 | 272% | - | - |
| t1/2 | h | 6.36 | - | - | - |
| CVCP | - | 0.49 | 81% | - | - |
| SDCP | mg/L | 0.055 (fixed) | - | - | - |
CL, clearance; CVCP, proportional residual error; F, absolute bioavailability of the oral dose (expressed as fraction of the administered dose), the median and range of the individual estimates are presented due to the wide distribution and use of a logit transformation to constrain F between 0 and 1 for each individual subject; IIV, inter-individual variability; ka, first-order absorption rate constant for oral dosing as a tablet or suspension; SDCP, additive residual error; t1/2, half-life; V, volume of distribution