Confidence Region Approach for Assessing Bioequivalence and Biosimilarity Accounting for Heterogeneity of Variability

Table 1

Data of the crossover trial.

Sequence	Subject number	Period		Subject total	P.D.	C.D.
		I	II
1
RT	1	74.675	73.675	148.350	−1.000	−1.000
RT	4	96.400	93.250	189.650	−3.150	−3.150
RT	5	101.950	102.125	204.075	0.175	0.175
RT	6	79.050	69.450	148.500	−9.600	−9.600
RT	11	79.050	69.025	148.075	−10.025	−10.025
RT	12	85.950	68.700	154.650	−17.250	−17.250
RT	15	69.725	59.425	129.150	−10.300	−10.300
RT	16	86.275	76.125	162.400	−10.150	−10.150
RT	19	112.675	114.875	227.550	2.200	2.200
RT	20	99.525	116.250	215.775	16.725	16.725
RT	23	89.425	64.175	153.600	−25.250	−25.250
RT	24	55.175	74.575	129.750	19.400	19.400
2
TR	2	74.825	37.350	112.175	−37.475	37.475
TR	3	86.875	51.925	138.800	−34.950	34.950
TR	7	81.675	72.175	153.850	−9.500	9.500
TR	8	92.700	77.500	170.200	−15.200	15.200
TR	9	50.450	71.875	122.325	21.425	−21.425
TR	10	66.125	94.025	160.150	27.900	−27.900
TR	13	122.450	124.970	247.420	2.525	−2.525
TR	14	99.075	85.225	184.300	−13.850	13.850
TR	17	86.350	95.925	182.275	9.575	−9.575
TR	18	49.925	67.100	117.025	17.175	−17.175
TR	21	42.700	59.425	102.125	16.725	−16.725
TR	22	91.725	114.050	205.775	22.325	−22.325

P.D. = 2 × (period difference).
C.D. = 2 × (crossover difference).