Table 3.
Test | Reference | Parametera | Adjusted geometric means | |||
---|---|---|---|---|---|---|
Test | Reference | Ratio (%)b | 90 % CI (%) | |||
PF-06439535 | Bevacizumab-EU | C max | 141.5 | 135.5 | 104.42 | 98.36–110.84 |
AUC0–t | 40,330 | 40,490 | 99.62 | 93.69–105.93 | ||
AUC0–∞ | 42,490 | 43,100 | 98.58 | 92.16–105.44 | ||
PF-06439535 | Bevacizumab-US | C max | 141.5 | 128.9 | 109.79 | 103.38–116.60 |
AUC0–t | 40,330 | 38,660 | 104.32 | 98.06–110.97 | ||
AUC0–∞ | 42,490 | 41,120 | 103.33 | 96.55–110.58 | ||
Bevacizumab-EU | Bevacizumab-US | C max | 135.5 | 128.9 | 105.15 | 99.05–111.62 |
AUC0–t | 40,490 | 38,660 | 104.71 | 98.48–111.34 | ||
AUC0–∞ | 43,100 | 41,120 | 104.82 | 98.00–112.12 |
AUC 0–∞ area under the serum concentration–time curve from zero extrapolated to infinity, AUC 0–t area under the serum concentration–time curve from time 0 to the time of the last quantifiable concentration, CI confidence interval, C max the maximum observed serum concentration
a C max, AUC0–t, and AUC0–∞ units are measured in μg/mL, μg·h/mL, and μg·h/mL, respectively
bTest-to-reference ratio of adjusted geometric means