Table II.
Summary of Final Population Enzyme Maturation Model Pharmacokinetic and Covariate Parameter Estimates for Complete Data Set
| Parameter (Unit) | Model Parameter Estimate (%RSE) |
|---|---|
| CL/F = (CL/F)Std_FF*fSize*fEM(HFF, AgeCL50FF)/fF | |
| (CL/F)Std_FF (L/h) | 23.7a (11.0) |
| HFF | 2.88 (23.5) |
| AgeCL50FF (mo) | 10.7 (6.4) |
| CL/F = (CL/F)Std_FS*fSize*fEM(HFS, AgeCL50FS)/fF | |
| (CL/F)Std_FS (L/h) | 23.7a (11.0) |
| HFS | 0.82 (37.5) |
| AgeCL50FS (mo) | 15.1 (20.9) |
| CL/F = (CL/F)Std_SS*fSize/fF | |
| (CL/F)Std_SS (L/h) | 7.35a (9.3) |
| V/F = (V/F)Std*fSize/fF | |
| (V/F)Std (L) | 53.3a (7.7) |
| fSize = (WT/70)Power | |
| Power for CL/F | 0.75 fixed |
| Power for V/F | 1 fixed |
| fF(AgeF50) | |
| AgeF50 (mo) | 1.18 (37.5) |
| Ka | 3 fixed |
| Residual variability | |
| Proportional (CV%) | 13.4 |
a
(CL/F)Std and (V/F)Std estimates in the final model are 70-kg body weight–normalized values. %RSE is percentage relative standard error. fSize, fEM, and fF are defined in the Methods section.