A Bioequivalence Test by the Direct Comparison of Concentration-versus-Time Curves Using Local Polynomial Smoothers

Table 2

The exact coverage of the 90% CIs for (the proposed measure of the difference between two curves) using simulations.

, (two curves are identical)
	100	100	100	100	100
	100	100	100	100	100
	99.9	100	100	100	100
	97.8	99.6	100	100	100
, (the difference is within the equivalence bound)
	100	100	100	100	100
	100	100	100	100	100
	98.7	99.7	100	100	100
	95.5	97.2	99.1	99.7	100
, (the difference is beyond the equivalence bound)
	0	0	0	0	0
	3.3	0.7	0.3	0	0
	11.6	6.6	3.7	3.2	0.7
	18	11.2	7.9	5.8	2.6
, (the difference is within the equivalence bound)
	100	100	100	100	100
	99.9	100	100	100	100
	97.7	99.1	99.7	100	100
	95	97.5	98.8	99.3	100
, (the difference is beyond the equivalence bound)
	0	0	0	0	0
	5	1.5	0.6	0.4	0
	13.2	8.2	5.4	3.8	0.7
	17.7	15.8	10.2	6.5	2.7

Note: represents the absorption rate for the generic drug and represents the absorption rate for the reference drug; represents the sample size of each group; represents a constant difference between the concentrations of two drugs on the logarithm scale; is the correlation coefficient between measures over time from the same subject; its influence on the estimation is expected to be bigger when its value is larger.