TABLE 3.
Statistical analysis of PK parameters of HD201, EU‐Herceptin®, and US‐Herceptin® (PKP population)
| Ratio (%) [90% CI] | |
|---|---|
| HD201 (N = 32) vs. EU‐Herceptin® (N = 34) | |
| AUC0–inf (h·µg/ml) | |
| HD201/EU‐Herceptin® | 102.45 [96.0; 109.4] |
| AUC0–last (h·µg/ml) | |
| HD201/EU‐Herceptin® | 103.5 [96.8; 110.8] |
| C max (µg/ml) | |
| HD201/EU‐Herceptin® | 104.6 [97.6; 112.2] |
| EU‐Herceptin® (N = 34) vs. US‐Herceptin® (N = 31) | |
| AUC0–inf (h·µg/ml) | |
| EU‐/US‐Herceptin® | 100.4 [93.9; 107.2] |
| AUC0–last (h·µg/ml) | |
| EU‐/US‐Herceptin® | 99.2 [92.7; 106.2] |
| C max (µg/ml) | |
| EU‐/US‐Herceptin® | 94.2 [87.8; 101.1] |
| HD201 (N = 32) vs. US‐Herceptin® (N = 31) (FDA) | |
| AUC0–inf (h·µg/ml) | |
| HD201/US‐Herceptin® | 102.8 [96.2; 110.0] |
| AUC0–last (h*µg/ml) | |
| HD201/US‐Herceptin® | 102.7 [95.8; 110.1] |
| C max (µg/ml) | |
| HD201/US‐Herceptin® | 98.52 [91.7; 105.8] |
Abbreviations: AUC0–inf, area under the concentration–time curve from 0 to infinity; AUC0–last, area under the concentration–time curve from 0 to last quantifiable analyte concentration; CI, confidence interval, n, number of subjects with the PK parameter; C max, maximum observed concentration; Mean, least squares mean.