Table 2.
Summary of pharmacokinetic parameter estimates obtained from the final model. Results from the initial model built using data from PENTA 13 and PENTA 15 studies are not shown
| Parameter | Notation | Population estimate* | %CV | Bootstrap mean (95% CI) |
|---|---|---|---|---|
| Clearance (CL) | ||||
| CL/F = θ1 × (BW/med)∧ θ5 | ||||
| (intercept) l h−1 | θ1 | 16.5 | 3.8 | 16.5 (15.2, 17.7) |
| (exponent) | θ5 | 0.705 | 14.9 | 0.701 (0.498, 0.911) |
| Volume (V) | ||||
| V/F = θ2 × (BW/med)∧ θ6 | ||||
| (intercept) l | θ2 | 46.0 | 3.7 | 46.0 (42.4, 49.5) |
| (exponent) | θ6 | 0.635 | 14.0 | 0.625 (0.461, 0.809) |
| Absorption rate constant (Ka) 1 h−1 | θ3 | 3.68 | 15.9 | 3.86 (1.92, 5.43) |
| ALAG1 h | θ4 | 0.755 | 4.5 | 0.755 (0.658, 0.851) |
| Weighing factor in $ERR | θ7 | −2.69 | 14.7 | −2.73 (−4.13, 1.24) |
| Interindividual variability | ||||
| ηCL/F variance | ω1 | 0.0684 (26%†) | 30.3 | 0.065 (0.032, 0.104) |
| ηV/F variance | ω2 | 0.0368 (19%†) | 52.8 | 0.035 (0.009, 0.06) |
| ηKa variance | ω3 | 0.438 (66%†) | 37.8 | 0.44 (0.098, 0.777) |
| Inter-occasion variability | ||||
| OCCCL | ω5 | 0.073 (27%‡) | 27.2 | 0.072 (0.024, 0.121) |
| OCCKa | ω7 | 0.53 (72%‡) | 42.5 | 0.52 (0.173, 0.886) |
| OCCV | ω9 | 0.04 (20%‡) | 32.73 | 0.039 (0.011, 0.069) |
| Residual error | ||||
| Additive error mg l−1 | σ1 | 0.005 (7%) | 21.48 | 0.005 (0.002, 0.007) |
*
Population parameter point estimates for the full one-compartment model are presented along with the %CV and 95% CI from a non-parametric bootstrap.
†
Value in parentheses represents the interindividual variability of the PK parameters calculated as the square root of ω × 100%.
‡
Value in parentheses represents the inter-occasion variability of the PK parameters calculated as the square root of the ω × 100%.