Simulation outline of bosutinib DDI and DDZI studies for model verification and application
| Study | Population | Bosutinib Dose | Treatment Day | Precipitant | Dose | Treatment Day | Analysis |
|---|---|---|---|---|---|---|---|
| mg | mg | ||||||
| DDI | HVs | 500 | 2 | Ketoconazole | 400 QD | 1–5 | Predicted versus observed |
| 7 | Rifampin | 600 QD | 1–10 | Predicted versus observed | |||
| 5 | Fluvoxamine | 50 QD | 1–8 | Predicted | |||
| 5 | Fluconazole | 200 QD | 1–8 | Predicted | |||
| 5 | Erythromycin | 250 QID | 1–8 | Predicted | |||
| 5 | Verapamil | 120 TID | 1–8 | Predicted | |||
| DDZI | RIPs | 200 | 1 | ― | ― | ― | Predicted versus observed |
| 1–28 | ― | ― | ― | Predicted | |||
| HIPs | 200 | 1 | ― | ― | ― | Predicted versus observed | |
| 1–28 | ― | ― | ― | Predicted |
Dashes indicate not applicable. QD, once daily; QID, four times a day; TID, three times a day.