Table IV.
FLU—simulated data | FLU—literature data (40–43) | TA—simulated data | TA—literature data (38,39,44) | |
---|---|---|---|---|
Mean | Range | Mean | Range | |
C max (ng/mL) | 1.30 | 0.81–2.39 | 0.18 | 0.12–0.25 |
t max (h) | 0.33 | 0.09–0.2 | 2.01 | 1.59–3.67 |
AUC0−inf (ng mL−1 h) | 1.92 | 1.52–4.28 | 0.90 | 0.69–1.92 |
Comparison of PK metrics from simulated data using the PK trial simulation tool (mean) and literature (range of means). AUC0−inf and C max data from literature were normalized to the simulated dose of 250 and 100 mcg for FLU and TA, respectively