Table 5.
Margin of safety (MOS).
| Compound | HED | Parameter | Mean | 1st percentile | 99th percentile | MOS |
|---|---|---|---|---|---|---|
| Thalidomide | In vitro HED1 10.06 mg/day | Cmax (μg/L) | 107.11 | 50.90 | 193.97 | 0.05 |
| AUC24 (μg*h/L) | 964 | 478 | 1725 | |||
| Therapeutic dose 50 mg/day | Cmax (μg/L) | 527.59 | 250.92 | 981.14 | ||
| AUC24 (μg*h/L) | 4767 | 2302 | 8934 | |||
| Carbamazepine | In vitro HED1 98.1 mg/day | Cmax (μg/L) | 1925 | 1070 | 3328 | 0.15 |
| AUC24 (μg*h/L) | 41817 | 22545 | 73209 | |||
| Therapeutic dose 200 mg/day | Cmax (μg/L) | 3889 | 2148 | 6859 | ||
| AUC24 (μg*h/L) | 84145 | 45964 | 150512 |
Human equivalent doses derived using the PBPK model and assuming the LOAEL concentration of 0.4 μM for thalidomide and 7.8 μM for carbamazepine from the ReproTracker are plasma concentrations.