Table 9.
Simulated against observed comparison on Cmax (ng/ml) and AUC0−t (ng × h/ml)
| Chemical | Observed Cmax (ng/ml) |
Predicted Cmax (ng/ml) |
Fold Difference (Simulated Mean/Observed Mean) | |||
|---|---|---|---|---|---|---|
| Geometric Mean | Range | Geometric Mean | Range | |||
| OMC | Day 1 | 2 | 0.6–5 | 2.9 | 0.22–7.6 | 1.5 |
| Day 4 | 7.9 | 2.6–30.6 | 9.9 | 1.1–24.7 | 1.3 | |
| Octocrylene | Day 1 | 1.5 | 0.5–3.6 | 1.7 | 0.4–3.3 | 1.2 |
| Day 4 | 7.8 | 2.6–38.7 | 5 | 1.3–11.3 | 0.6 | |
| 4-MBC | Female | 25.5 | 19.8–31.2 | 21.7 | 9.8–40.0 | 0.9 |
| Male | 51.9 | 19.8–83.9 | 31.8 | 9.1–76.6 | 0.6 | |
| Chemical |
Observed AUC0
−
t (ng × h/ml)
|
Predicted AUC0
−
t
(ng × h/ml)
|
Fold Difference (Simulated Mean/Observed Mean) | |||
|---|---|---|---|---|---|---|
| Geometric mean | Range | Geometric mean | Range | |||
| OMC | Day 1 | 21.6 | 2.7–57.7 | 32.9 | 1.9–81.0 | 1.5 |
| Day 4 | 103.4 | 45.1–213.5 | 276.0 | 87.3–705 | 2.7 | |
| Octocrylene | Day 1 | 20.0 | 6.4–38.1 | 28.7 | 5.0–49.7 | 1.4 |
| Day 4 | 94.7 | 41.4–210.0 | 128.6 | 26.6–245.2 | 1.4 | |
| 4-MBC | Female | 485.6 | NA | 373.8 | 160.1–692.2 | 0.8 |
| Male | 987.9 | NA | 583.5 | 153.1–1374.9 | 0.6 | |
NA, not available.