Table 2.
Summary of PK parameters (PK population)
| Parameter | SB8 (N = 38) | Bevacizumab-EU (N = 38) | Bevacizumab-US (N = 38) |
|---|---|---|---|
| AUCinf (h·μg/mL) | 25,354.4 ± 4833.10 | 28,896.8 ± 6221.62 | 28,684.8 ± 5425.14 |
| AUClast (h·μg/mL) | 24,199.2 ± 4367.53 | 27,342.2 ± 5374.53 | 27,177.9 ± 4770.93 |
| Cmax (μg/mL) | 76.259 ± 14.6999 | 76.059 ± 11.7053 | 76.485 ± 16.9916 |
| Tmax (hour) | 3.000 (1.52, 12.00) | 3.000 (1.52, 12.00) | 3.000 (1.52, 97.12) |
| t1/2 (hour) | 444.4 ± 79.46 | 464.2 ± 81.06 | 462.8 ± 86.98 |
| Vz (mL) | 6,118.6 ± 960.98 | 5,566.4 ± 833.62 | 5,654.1 ± 999.97 |
| CL (mL/hour) | 9.721 ± 1.7803 | 8.517 ± 1.6570 | 8.659 ± 1.8600 |
Data are presented in mean ± SD except Tmax which is presented in median (min, max)
AUCinf area under the concentration–time curve from time zero to infinity, AUClast area under the concentration–time curve from time zero to the last quantifiable concentration, Bevacizumab-EU bevacizumab sourced from the European Union, Bevacizumab-US bevacizumab sourced from the United States, CL total body clearance, Cmax maximum observed serum concentration, N number of participants in the PK population, SD standard deviation, Tmax time at which Cmax was observed, t1/2 terminal half-life, Vz volume of distribution during the terminal phase