Table 3.
Statistical assessment of pharmacokinetic parameters
| PK parameters | |||
|---|---|---|---|
|
C
max (μg/mL) Adjusted LS GM (n) |
AUCinf (μg h/mL) Adjusted LS GM (n) |
AUClast (μg h/mL) Adjusted LS GM (n) |
|
| ABP 980 | 135.9 (50) | 34061.4 (50) | 33811.7 (50) |
| Trastuzumab (US) | 131.2 (52) | 32271.7 (48) | 32113.6 (48) |
| Trastuzumab (EU) | 136.8 (54) | 33947.0 (46) | 33748.2 (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) vs 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