Table 3.

Statistical comparison of pharmacokinetic exposure parameters between test and reference products

Test	Reference	Parameter*	Geometric mean		Ratio (%)‡	90% CI (%)
			Test	Reference
PF-05280014	Trastuzumab-EU	Cmax	157	171	91.49	85.32, 98.09
			35210	38000	92.66	86.44, 99.34
		AUC(0,∞)	36650	39770	92.15	86.03, 98.69
PF-05280014	Trastuzumab-US	Cmax	157	161	97.41	90.71, 104.62
			35210	35230	99.94	93.08, 107.31
		AUC(0,∞)	36650	36710	99.83	93.06, 107.09
Trastuzumab-EU	Trastuzumab-US	Cmax	171	161	106.48	99.20, 114.30
			38000	35230	107.85	100.50, 115.75
		AUC(0,∞)	39770	36710	108.34	101.05, 116.16

^*C_max, and AUC_(0,∞) were in units of μg ml⁻¹, μg ml⁻¹ h and μg ml⁻¹ h, respectively.

^†Ratio of adjusted geometric means. , 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; CI, confidence interval; C_max, maximum drug concentration.