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. 2014 Nov 20;78(6):1281–1290. doi: 10.1111/bcp.12464

Table 2.

Mean ± SD pharmacokinetic parameter estimates

PF-05280014 Trastuzumab-EU Trastuzumab-US
Subjects (n) 34 35 32
Cmax (μg ml−1) 159 ± 26 174 ± 31 164 ± 31
Inline graphic (μg ml−1 h)* 35700 ± 6287 38510 ± 6569 35870 ± 6878
AUC(0,∞) (μg ml−1 h) 37130 ± 6305 40330 ± 6994 37310 ± 6728
CL (ml h−1 kg−1) 0.166 ± 0.026 0.153 ± 0.025 0.166 ± 0.032
Vss (ml kg−1) 56.1 ± 8.2 51.7 ± 6.9 55.7 ± 8.8
t1/2 (h) 213 ± 42 220 ± 42 212 ± 47
*

Inline graphic was ≥80% of corresponding AUC(0,∞) in all PK eligible subjects. Inline graphic, area under the concentration–time curve from time 0 to last time point of measurable concentration; AUC(0,∞), area under the concentration–time curve from time 0 extrapolated to infinite time; CL, clearance; Cmax, maximum drug concentration; SD, standard deviation; t1/2, terminal half-life; Vss, volume of distribution at steady-state.