Observed and predicted RSV AUC ratios with RIF as an inhibitor in cynomolgus monkeys and humans
Species | AUC Ratio (Observed) | 90% CI of AUC Ratio | AUC Ratio (Predicted) | ||||||
---|---|---|---|---|---|---|---|---|---|
Prediction Methoda | Imax | Iave | Iin,max | ||||||
Total | Free | Total | Free | Total | Free | ||||
Cynomolgus Monkey | 2.89 | 1.42–5.31 | Eq. 1 | 33.93 | 7.26 | 11.04 | 2.91 | 63.04 | 12.79b |
Human | 3.00 | 2.51–3.52 | 9.51 | 2.70 | 5.06 | 1.81 | 19.72 | 4.74b | |
Cynomolgus Monkey | 2.89 | 1.42–5.31 | Eq. 2 | 3.32 | 2.64 | 2.90 | 1.90 | 3.43 | 2.97 |
Human | 3.00 | 2.51–3.52 | 2.81 | 1.83 | 2.37 | 1.48 | 3.16 | 2.32 | |
Cynomolgus Monkey | 2.89 | 1.42–5.31 | Eq. 3 | 3.03 | 2.13 | 2.41 | 1.54 | 3.25 | 2.51 |
Human | 3.00 | 2.51–3.52 | 2.78 | 1.81 | 2.34 | 1.47 | 3.14 | 2.29 |
AUC, area under the concentration-time curve; CI, confidence interval; RIF, rifampin; RSV, rosuvastatin.
↵a Fold AUC change predicted using different methods or equations (see Materials and Methods).
↵b Calculated R-value using the approach recommended by US Food and Drug Administration and International Transporter Consortium.