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. Author manuscript; available in PMC: 2019 Dec 1.
Published in final edited form as: J Clin Pharmacol. 2018 Sep 25;58(12):1604–1617. doi: 10.1002/jcph.1293

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) = 50(WT70)0.75  F=(1EH)Θ4Formulation(1+Θ5(1e(AGEY0.115)Θ6))
*

Bootstrap had a convergence rate of 85.1%.

**

Plateau Maturation Effect is represented by both Maturation Effect on FABS5) 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