TABLE 3.

Analysis of bioequivalence for plasma pharmacokinetic parameters of sorafenib under fasted conditions.

PK parameters	GM		ABE		RSABE
	T (N = 71)	R (N = 70)	T/R (%)	90%CI (Lower, Upper)	CVWR (%)	CVWT (%)	GMR point estimators [80.00%,125.00%]	Critical Bound [≤0]
Cmax (ng/mL)	1,083.97	1,250.43	86.69	(75.89,99.02)	41.93	39.82	88.97	−0.05
AUC0-t (ng·h/mL)	22,213.80	27,570.57	80.57	(71.78,90.44)	45.64	38.14	81.67	−0.03
AUC0- $\infty$ (ng·h/mL)	24,444.11	29,448.84	83.01	(74.64,92.31)	43.75	35.16	83.66	−0.04

Notes: Within-subject coefficient of variation (CV%) was calculated using the exact formula:CV% = 100×sqrt (exp (S_wr^2)-1), where S_wr^2 is the within-subject variance estimated from the linear mixed-effects model. Abbreviations: PK, Pharmacokinetics; GM, geometric mean; ABE, average bioequivalence; RSABE, reference-scaled average bioequivalence; T, test formulation; R, reference formulation; CI, confidence intervals; CV_wr, within-subject coefficient of variation (reference); CV_wt, within-subject coefficient of variation (test); GMR, geometric mean ratios; C_max, maximum observed plasma concentration; AUC_0-t, area under the curve from time 0 to the time of the last quantifiable concentration; AUC_{0- $\infty$} , area under the curve from time 0 extrapolated to infinity.