TABLE 5.
Final population PK parameters and bootstrap results for SDX and NSXa
| Parameter | Value |
|
|---|---|---|
| Final model | Bootstrap (n = 1,000) [median (95% CI)] | |
| OFV | −521.177 | −529.222 (−647.701 to −428.084) |
| PK parameters [estimate (% RSE)] | ||
| ka (per h) | 1.23 | Fixed |
| V/F (liters/70 kg) | 24.2 (4) | 24.2 (22.5-26.1) |
| CLR/F (liters/h/70 kg) | 0.0046 (113) | 0.0086 (0.0005-0.0267) |
| CLH/F (liters/h/70 kg) | 0.0458 (16) | 0.0427 (0.0290-0.0640) |
| MATCL50 (days) | 271 (8) | 286 (248-360) |
| HillCL | 4.07 (52) | 4.61 (1.56-15.54) |
| Relative dose on relative bioavailability (power) | −0.56 (14) | −0.54 (−0.71 to −0.38) |
| % NSX (%) | 60 | Fixed |
| VNSX/F(liters/70 kg) | 11.7 (10.7) | 11.7 (9.4-14.4) |
| CLNSX/F(liters/h/70 kg) | 0.758 (5) | 0.756 (0.690-0.838) |
| Random parameters [CV% (% RSE)] | ||
| BSV V/F | 23.0 (11) | 22.2 (17.1-26.5) |
| BSV CLT/F | 23.8 (11) | 23.4 (17.9-28.3) |
| BSV VNSX/F | 42.8 (19) | 41.7 (21.0-56.3) |
| BSV CLNSX/F | 36.2 (26) | 35.6 (25.5-45.1) |
| Correlations between BSV pairs | ||
| R (V/F, CLT/F) | 0.644 (26) | 0.653 (0.439-0.814) |
| R(VNSX/F, CLNSX/F) | 0.218 (126) | 0.226 (−0.474 to 0.729) |
| Residual unexplained variability [CV% (% RSE)] | ||
| Proportional error, SDX | 16.5 (11) | 16.4 (12.9-20.1) |
| Proportional error, NSX | 37.1 (9) | 37.0 (30.2-43.1) |
a
Parameters for NSX modeling obtained after fixing model parameters for SDX are highlighted in bold. % RSE, percent relative standard error.