Table 3.
Linear regression analysis of dose-proportionality for PB-201 and WI-0800
| β point estimate | 90% CI of β | Predefined criterion of linearity | |
|---|---|---|---|
| Day 1, PB-201 | |||
| Cmax | 1·04 | 0·714–1·500 | 0·678–1·320 |
| AUC0–last | 1·12 | 0·790–1·590 | 0·678–1·320 |
| AUC0–inf | 1·12 | 0·781–1·590 | 0·678–1·320 |
| Day 1, WI-0800 | |||
| Cmax | 1·27 | 0·886–1·810 | 0·678–1·320 |
| AUC0–last | 1·31 | 0·923–1·860 | 0·678–1·320 |
| Day 7, PB-201 | |||
| Cmax | 1·15 | 0·867–1·530 | 0·678–1·320 |
| AUC0–last | 0·98 | 0·734–1·310 | 0·678–1·320 |
| AUC0–inf | 0·96 | 0·708–1·290 | 0·678–1·320 |
| Day 7, WI-0800 | |||
| Cmax | 1·11 | 0·827–1·490 | 0·678–1·320 |
| AUC0–last | 1·19 | 0·835–1·700 | 0·678–1·320 |
AUC0–inf=area under the concentration–time curve from time zero to infinity. AUC0–last=area under the concentration–time curve from time zero to the last measurable concentration. Cmax=maximum plasma concentration. β=linear correlation coefficient.