Table 2.
Statistical assessment of pharmacokinetic parameters [14]
| PK parameters | |||
|---|---|---|---|
| Cmax (μg/mL) | AUCinf (μgh/mL) | AUClast (μgh/mL) | |
| Adjusted LS GM (n) | |||
| ABP 980 | 135.9 (50) | 34,061.4 (50) | 33,811.7 (50) |
| Trastuzumab (US) | 131.2 (52) | 32,271.7 (48) | 32,113.6 (48) |
| Trastuzumab (EU) | 136.8 (54) | 33,947.0 (46) | 33,748.2 (46) |
| Statistical analysis: ratio and 90% CI of adjusted least square geometric means | |||
| ABP 980 versus trastuzumab (US) | 1.04 (0.9948–1.0787) | 1.06 (0.9974–1.1169) | 1.05 (0.9967–1.1122) |
| ABP 980 versus trastuzumab (EU) | 0.99 (0.9540–1.0338) | 1.00 (0.9476–1.0624) | 1.00 (0.9479–1.0589) |
| Trastuzumab (US) versus trastuzumab (EU) | 0.96 (0.9213–0.9975) | 0.95 (0.8973–1.0072) | 0.95 (0.8998–1.0063) |
Statistical model includes treatment and ethnicity as fixed effects
GM geometric means, LS least squares, n number of non-missing observations