Table 6.
Predicted and actual mean values of Cmax and AUC of dersimelagon after 100 mg oral administration in humans
| Model | Cmax (ng/mL) |
Ratio of Cmax (predicted/actual) |
AUC (ng/mL) |
Ratio of AUC (predicted/actual) |
|---|---|---|---|---|
| Actual | 339.6 | - | 2588.2 | - |
| Simple allometry | 203.9 | 0.60 | 463.8 | 0.18 |
| Allometry with bile flow correction factor | 363.1 | 1.07 | 901.4 | 0.35 |
| Allometry with the rule of exponent | 250.3 | 0.74 | 583.9 | 0.23 |
| Allometry with unbound clearance approach | 957.3 | 2.82 | 3400.9 | 1.31 |
| Fu-corrected intercept method | 595.6 | 1.75 | 1689.0 | 0.65 |
AUC area under the plasma concentration–time curve, Cmax maximum observed plasma concentration; fu, fraction unbound