The virtual clinical trials design and observed and predicted mean PK parameters for oseltamivir in adults and infants
| Parameter | |||
| Population type | Healthy adult volunteers | Pediatric | |
| Maximum age (years) | 45 | 1 | |
| Minimum age (years) | 18 | 0 | |
| Number of trials | 10 | 10 | |
| Number of subjects per trial | 10 | 10 | |
| Total number of subjects | 100 | 100 | |
| Study duration (hours) | 13 | 13 | |
| Number of time samples | 200 | 200 | |
| Dose | 150 mg | 3 mg/kg | |
| Dosing regimen | Single dose | Single dose | |
| Fluid intake with dose (ml) | 250 | 100 | |
| Fasted or fed | Fasted | Fasted | |
| Mean PK parameters for oseltamivir in adults | |||
| Mean PK parameter | Observed | Predicted | Predicted/Observed Ratio |
| AUC (ng/ml×h) | 297 | 270 | 1.1 |
| Cmax (ng/ml) | 99 | 117 | 0.9 |
| Tmax (h) | 0.95 | 0.77 | 1.2 |
| Mean PK parameters for oseltamivir in infants | |||
| Mean PK parameter | Observed | Predicted | Predicted/Observed Ratio |
| AUC (ng/ml×h) | 308 | 566 | 1.8 |
| Cmax (ng/ml) | 78 | 166 | 2.1 |
| Tmax (h) | 0.9 | 1.17 | 1.3 |