Table 2.
Summary of pharmacokinetic parameters
| Parameter | ABP 980 | Trastuzumab (US) | Trastuzumab (EU) |
|---|---|---|---|
|
C
max (μg/mL), GM (n) (GeoCV%) |
139.9 (50) (13) |
134.6 (52) (13) |
140.5 (54) (12) |
|
C
last (μg/mL), GM (n) (GeoCV%) |
0.717 (50) (97) |
0.574 (48) (91) |
0.630 (46) (97) |
| AUClast, (μg h/mL), GM (n) (GeoCV%) |
34,945 (50) (17) |
33,160 (48) (17) |
34,896 (46) (17) |
| AUCinf, (μg h/mL), GM (n) (GeoCV%) |
35,224 (50) (18) |
33,342 (48) (17) |
35,123 (46) (18) |
| t max (h), median (range) (n) | 2.0 (1.52–5.00) (50) |
2.0 (1.53–5.00) (52) |
2.0 (1.55–24.00) (54) |
| t ½ (h), mean (SD) (n) | 169.4 (40.82) (50) |
154.0 (27.97) (48) |
154.8 (39.78) (46) |
GeoCV% geometric mean coefficient of variation, AUC area under the serum concentration–time curve, AUC inf AUC from time 0 extrapolated to infinity, AUC last AUC from time 0 to the last quantifiable concentration, CI confidence interval, C max maximum serum concentration, LS least squares, t max time at which the maximum serum concentration was observed, t½ terminal elimination half-life, Max maximum, Min minimum, SD standard deviation, GM geometric mean, n number of non-missing observations