Efficacy, safety and population pharmacokinetics of sapropterin in PKU patients <4 years: results from the SPARK open-label, multicentre, randomized phase IIIb trial

Table 3 Parameter estimates for final model

	Population mean	SE%
CL/F (L/h)	2780	2.0
V/F (L)	3870	5.9
K_a (1/h)	0.234	6.6
LAG (h)	0.342	2.8
C0 (μg/L)	12.6	7.8
Coefficient describing effect of weight on CL/F	0.839	1.8
Coefficient describing effect of weight on V/F	0.573	3.3
Residual error (%CV)	65.30	8.5
IIV_CL (%CV)	22.98	0.2
IIV_V2 (%CV)	32.56	0.2
Corr (CL,V)	0.134	NE

SE standard error, CL/F apparent clearance, V/F apparent volume of distribution, LAG, lag time, K _a absorption rate constant, C0 endogenous BH₄ concentrations, CV coefficient of variation, IIV between-subject variability, NE not estimated

ISSN: 1750-1172