Table 2.
Parameter estimates for final population PK model
| Parameter | Final Value | SE | Median Bootstrap Estimate* (95% Confidence Interval) |
|---|---|---|---|
| Θ1 (EH) | 0.14 | 0.03 | 0.15 (0.10 – 0.22) |
| Θ2 (VD) | 1.61 | 0.34 | 1.63 (1.04 – 2.5) |
| Θ3 (KA) | 0.31 | 0.06 | 0.31 (0.15 – 0.40) |
| Θ4 (Tablet) | 1.23 | 0.11 | 1.23 (1.03 – 1.47) |
| Θ5** (Maturation Effect on F) | 0.97 | 0.46 | 1.09 (0.57 – 2.28) |
| Θ6** (Half-life of Maturation) | 0.98 | 0.63 | 0.97 (0.02 – 6.90) |
| Between Subject Variability (BSV)** | |||
| BSV, EH | 42% | 2% | 41% (35% - 47%) |
| BSV, VD | 48% | 3% | 71% (57% −82%) |
| BSV interaction, (EH-VD) | 38% | 2% | 47% (41% - 53%) |
| Error | |||
| Proportional | 9.4% | 0.03 | 9.6% (0.4% - 15.2%) |
| Additive (μg/mL) | 2.13 | 0.16 | 2.11 (1.71–2.40) |
| EH =Θ1 CL (L/hr) = EH • QHP VD (L) = Θ2 • WT KA (1/hr) = Θ3 | |||
| QHP (L/hr) = | |||
Bootstrap had a convergence rate of 85.1%.
Plateau Maturation Effect is represented by both Maturation Effect on FABS (Θ5) and Half-life of Maturation (Θ6)
BSV was not assessed on FABS or KA.
F represents relative bioavailability with a reference value F=1 for an infant 0.115 years of age receiving the liquid formulation