Table 3.
Summary of recombinant factor IX Fc (rFIXFc) population pharmacokinetic final model
| Parameter | Model estimate | Bootstrap median (95 % CIa) |
|---|---|---|
| CL = typical CL × ()0.436 | ||
| Typical CL for a 73 kg patient (dL/h) | 2.39 | 2.39 (2.29, 2.49) |
| BW exponent on CL | 0.436 | 0.437 (0.272, 0.584) |
| V 1 = typical V 1 × ()0.396 | ||
| Typical V 1 for a 73 kg patient (dL) | 71.4 | 71.2 (58.5, 76.0) |
| BW exponent on V 1 | 0.396 | 0.390 (0.169, 0.580) |
| Q 2 (dL/h) | 1.67 | 1.66 (1.35, 1.89) |
| V 2 (dL) | 87.0 | 87.0 (79.0, 95.5) |
| Q 3 (dL/h) | 39.3 | 39.0 (16.6, 141) |
| V 3 (dL) | 39.9 | 41.2 (36.6, 52.4) |
| IIVb on CL, % | 17.7 | 17.5 (11.8, 22.4) |
| IOVc on CL, % | 15.1 | 15.0 (10.7, 19.1) |
| IIV on V 1, % | 21.7 | 22.4 (15.5, 32.1) |
| IOV on V 1, % | 17.4 | 16.5 (8.7, 22.8) |
| IIV on Q 2, % | 35.8 | 35.0 (22.6, 45.8) |
| IIV on V 2, % | 46.2 | 45.9 (38.0, 55.3) |
| IIV on V 3, % | 37.7 | 37.9 (30.2, 54.3) |
| Correlation between IIV on CL and V 1, % | 75.6 | 74.8 |
| Proportional residual error, % | 10.6 | 10.4 (8.64, 12.0) |
| Additive residual error, IU/dL | 0.24 | 0.24 (0.17, 0.31) |
BW body weight, CI confidence interval, CL clearance, IIV inter-individual variability, IOV inter-occasion variability, Q 2 inter-compartmental clearance of compartment 2, Q 3 inter-compartmental clearance of compartment 3, V 1 volume of compartment 1, V 2 volume of compartment 2, V 3 volume of compartment 3
a95 % CI, non-parametric 95 % CI from bootstrap results with 1,000 datasets
bIIV calculated as × 100
cIOV calculated as × 100