TABLE 3.
Simulated exposures by PNA group using different dosing regimens
| PNA and parametera | Dose, duration |
|||||
|---|---|---|---|---|---|---|
| 8 mg/kg, 24 h | 8 mg/kg, 12 h | 10 mg/kg, 24 h | 12 mg/kg, 24 h | 15 mg/kg, 24 h | 20 mg/kg, 24 h | |
| PNA < 14 days | ||||||
| Cmax-fd (μg/ml) | 7.0 ± 1.9 | 11.5 ± 2.5 | 8.8 ± 2.4 | 10.6 ± 2.8 | 13.4 ± 3.7 | 17.6 ± 4.7 |
| Cmax-ss (μg/ml) | 8.3 ± 1.8 | 16.2 ± 4.4 | 10.4 ± 2.3 | 12.5 ± 2.7 | 15.6 ± 3.4 | 20.7 ± 4.5 |
| AUC∞ (μg ⋅ h/ml) | 84.8 (30.2–193.0) | 172.7 (70.0–405.0) | 106.0 (37.8–241.3) | 127.1 (45.3–289.5) | 155.9 (49.5–361.4) | 212.0 (75.5–482.5) |
| TA (%) | 92.3 | 100 | 97.8 | 99.1 | 99.7 | 100 |
| PNA ≥ 14 days | ||||||
| Cmax-fd (μg/ml) | 6.7 ± 1.7 | 7.4 ± 1.5 | 8.4 ± 2.1 | 10.1 ± 2.5 | 12.9 ± 3.4 | 16.8 ± 4.1 |
| Cmax-ss (μg/ml) | 6.9 ± 1.6 | 8.2 ± 1.7 | 8.6 ± 2.0 | 10.3 ± 2.4 | 13.2 ± 3.3 | 17.1 ± 3.9 |
| AUC∞ (μg ⋅ h/ml) | 39.2 (15.1–96.7) | 68.1 (30.0–141.8) | 49.0 (18.9–120.8) | 58.8 (22.7–145.0) | 72.6 (28.1–165.8) | 97.9 (37.8–241.6) |
| TA (%) | 8.9 | 76.2 | 30.7 | 56.7 | 91.5 | 97.8 |
a
Cmax-fd and Cmax-ss, mean (standard deviation); AUC∞, median (minimum to maximum); TA, % target attainment rate = (no. of subjects with AUC∞ > 55.2 μg ⋅ h/ml/total number of subjects in the group) × 100.