Table 3.
PK parameter | Value | SE | CV | 95% CI |
---|---|---|---|---|
CL, dL/h | 1.63 | 0.159 | 9.75 | 1.32–1.95 |
V1, dL | 39.4 | 1.26 | 3.20 | 36.9–41.9 |
Q rurioctocog alfa pegol, dL/h | 3.00 | 0.726 | 24.2 | 1.58–4.43 |
V2 rurioctocog alfa pegol, dL | 5.32 | 0.817 | 15.4 | 3.72–6.92 |
Relative increase in CL for rurioctocog alfa pegol | 1.21 | 0.0396 | 3.27 | 1.13–1.29 |
Interindividual variability in CL, %CV | 41.2 | 0.0615 | 36.3 | 0.0491–0.290 |
Interindividual variability in V1, %CV | 13.0 | 0.00574 | 34.1 | 0.00558–0.0281 |
Interindividual variability in relative increase in CL for rurioctocog alfa pegol versus damoctocog alfa pegol, %CV | 11.5 | 0.00429 | 32.4 | 0.00484–0.0217 |
Interindividual variability for Q rurioctocog alfa pegol, %CV | 15.0 (fix) | – | – | – |
Interindividual variability for V2 rurioctocog alfa pegol, %CV | 15.0 (fix) | – | – | – |
Residual error (additive) | 0.25 (fix) | – | – | – |
Residual error (proportional) | 0.117 | 0.00499 | 4.26 | 0.107–0.127 |
CI, confidence interval; CL, clearance; CV, coefficient of variation; LBW, lean body weight; PK, pharmacokinetic; Q, intercompartmental clearance; SE, standard error; V, volume