Table 3.
Parameter estimates of the popPK model
| Parameter | Value | RSE (%) | 5% CI | 95% CI |
|---|---|---|---|---|
| CL (dL/h) | 1.57 | 10.5 | 1.25 | 1.89 |
| Vc of distribution (dL) | 28.3 | 3.59 | 26.3 | 30.3 |
| Q (dL/h)a | 0.69 | 20.2 | 0.42 | 0.96 |
| Vp of distribution (dL)a | 6.02 | 14.5 | 4.31 | 7.72 |
| Effect of LBW on CL | 1.03 | 32.9 | 0.364 | 1.69 |
| Effect of LBW on Vc of distribution | 1.10 | 15.5 | 0.765 | 1.43 |
| Relative reduction of CL for BAY 94-9027 compared with rFVIIIFcb | − 0.21 | 14.0 | − 0.26 | − 0.15 |
| Inter-individual variability in CL (variance [%CV]) | 0.11 (33.3) | 28.5 | 0.05 | 0.16 |
| Inter-individual variability in Vc of distribution (variance [%CV]) | 0.01 (11.1) | 34.2 | 0.004 | 0.02 |
| Inter-individual variability in change in CL for BAY 94-9027 compared with rFVIIIFc (variance [%CV]) | 0.20 (46.4) | 51.4 | − 0.002 | 0.39 |
| Residual error, additive component (variance) | 0.296 | 18.2 | 0.190 | 0.40 |
| Residual error, proportional component (variance [%CV]) | 0.09 (29.7) | 6.63 | 0.08 | 0.10 |
aOnly applies for rFVIIIFc
bCL (BAY 94-9027) = CL (rFVIIIFc) × (1+ relative reduction in CL)
CL, clearance; %CV, coefficient of variation; LBW, low body weight; Q, intercompartmental CL; RSE, relative standard error; Vc, central volume; Vp, peripheral volume