TABLE 2.
Summary of PK parameters for trastuzumab (PKP population)
| Parameter |
HD201 N = 32 |
EU‐Herceptin® N = 34 |
US‐Herceptin® N = 31 |
|---|---|---|---|
| AUC0–inf (h·µg/ml) | |||
| Geometric mean | 38 350 | 37 433 | 37 299 |
| Geometric CV (%) | 16.0 | 16.7 | 15.5 |
| AUC0–last (h·µg/ml) | |||
| Geometric mean | 36 588 | 35 337 | 35 620 |
| Geometric CV (%) | 17.6 | 17.0 | 15.3 |
| C max (µg/ml) | |||
| Geometric mean | 148.8 | 142.3 | 151.1 |
| Geometric CV (%) | 19.5 | 15.5 | 16.6 |
| t max (h) | |||
| Median | 1.7 | 3.2 | 1.6 |
| Mean | 2.9 | 3.6 | 3.3 |
| SD | 1.5 | 2.6 | 2.8 |
| t 1/2el (h) | |||
| Mean | 234.2 | 243.1 | 238.5 |
| SD | 26.3 | 36.5 | 34.9 |
| CV (%) | 11.2 | 15.0 | 14.6 |
| K el (1/h) | |||
| Geometric mean | 297.7 | 288.0 | 293.6 |
| Geometric CV (%) | 11.1 | 14.2 | 14.2 |
| CL (ml/h) | |||
| Geometric mean | 12.3 | 12.4 | 11.9 |
| Geometric CV (%) | 16.9 | 17.3 | 18.5 |
| V d (ml) | |||
| Geometric mean | 4133.3 | 4112.2 | 4056.2 |
| Geometric CV (%) | 17.3 | 19.8 | 18.7 |
Abbreviations: AUC0–inf, area under the concentration–time curve from time 0 extrapolated to infinity; AUC0–last, area under the concentration–time curve from time 0 to the last quantifiable data point; C max, maximum observed concentration; CV (%), coefficient of variation; Geo. CV (%), geometric coefficient of variation; Geo. Mean, geometric mean; K el, terminal elimination rate constant CL, systemic clearance; SD, standard deviation; t 1/2, terminal half‐life; t max, time of maximum observed concentration; V d, volume of distribution.