Table II.
Performance check of BUD module of the ICSpkTS R extension package
| Simulated data | Study I—Moellmann et al. (30) | Study II—Harrison et al. (35) | Study III—Mortimer et al. (36) | Study IV—Dalby et al. (37) | |
|---|---|---|---|---|---|
| n | 1,000 | 14 | 12 | 20 | 26 |
| C max (ng/mL) | 1.39 (27.2) | 0.89 (54.3) | 2.02 (−) | 2.09 (49) | 2.26 (−) |
| t max (h) | 0.65 (92.3) | 0.41 (84.3) | – | 0.21 (114) | 0.5 (−) |
| AUC0–24 (ng mL−1 h) | 4.74 (27.2) | 2.56 (60.0) | – | – | – |
| AUC0–inf (ng mL−1 h) | 4.77 (27.4) | 2.84 (56.3) | – | – | – |
| AUC0−5/6 a (ng mL−1 h) | 3.63 (26.4) | – | – | 3.59 (41.4) | – |
| AUC0−8 (ng mL−1 h) | 4.06 (25.9) | – | 5.39 (−) | – | – |
| AUC0−10 (ng mL−1 h) | 4.32 (25.9) | – | – | – | 3.3 (106.4) |
| Terminal t 1/2 (h) | 2.62 (39.3) | 2.97 (48.4) | – | – | – |
Comparison of PK metrics (mean (CV%)) from simulated data using the PK trial simulation tool and literature. Only data from healthy subjects were used from literature. AUC and C max data from literature were normalized to the simulated dose of 1,000 mcg
n number of subjects
aAUC0−5 for simulated data and AUC0−6 for literature data