Table 1.
Comparison of Pharmacokinetic Parameters in Simulation to Patients
| Domain of Input in Subroutine PRIOR | 10000 Simulated Subjects | FDA Gatifloxacin Label Information | |
|---|---|---|---|
| Clearance in L/hr (mean ± SD) | 6.2 ± 2.0 | 6.1 ± 2.0 | 8.8 ± 1.5a |
| Volume in L (mean ± SD) | 141.0 ± 31.0 | 141.0 ± 8.8 | ... |
| Absorption constant (hr-1) | 1.3 ± 0.4 | 1.3 ± 0.6 | ... |
| 200 mg oral | |||
| AUC0-24 mg*hr/L | ... | 20.8 ± 2.8 | 14.2 ± 0.4b |
| Peak concentration in mg/L | ... | 1.3 ± 0.1 | 2.0 ± 0.4b |
| 400 mg oral | |||
| AUC0-24 mg*hr/L | ... | 41.6 ± 5.6 | 51.3 ± 20.4a |
| Peak concentration in mg/L | ... | 2.5 ± 0.2 | 4.2 ± 1.9a |
Abbreviations: AUC, area under the concentration-time curve; FDA, Food and Drug Administration; SD, standard deviation.
aMultiple dose in patients with non-tuberculous infection.
bHealthy volunteers, single dose.