Table 3.
Parameter estimates and bootstrap analysis of the blinatumomab population pharmacokinetic parameters (n = 674)
| Parameter | Final model (mean (RSE, %) [95% CI]) | Non-parametric bootstrap: 500 successful of 500 replicates (median [95% CI]) |
|---|---|---|
| Pharmacokinetic parameters | ||
| Volume (L) | 5.98 (8.86) [5.14–6.98] | 5.99 [5.14–6.98] |
| CL (L/h) | 2.22 (2.95) [2.08–2.35] | 2.22 [2.08–2.35] |
| Effect of BSA on CL (θ)a | 0.620 (12.7) [0.46–0.76] | 0.625 [0.463–0.756] |
| Inter-individual variability (%CV) | ||
| ωCL | 47.6 (16.1) [38.1–54.2] | 47.1 [38.1–54.1] |
| ωEPS | 64.3 (14.5) [55.0–73.0] | 64.4 [55.0–73.0] |
| Residual variability (%CV) | 55.9 (3.99) [52.6–61.5] | 56.1 [46.3–75.6] |
BSA body surface area, CI confidence interval obtained from NONMEM® asymptotic standard errors, CL clearance, CV coefficient of variation, RSE relative standard error, ωCL inter-subject variability in CL, ωEPS inter-subject variability in residual variability
aCLindividual = CL·(BSA/1.876)Effect of BSA on CL