Table 3.

Classic confidence interval for bioequivalence and Schuirmann's test to compare Lyrica^™ (reference) and Pregobin^™ (test) parameters in healthy volunteers.

Classic confidence interval for bioequivalence						Schuirmann's test
	Equivalence limits reference (%)		Test limits (%)		Bioequivalence probability (%)*	Two one-side test		p-value
Ln Cmax
difference	−0.141	0.141	−0.023	0.091	96.00	Upper side	−3.243	0.004
Ratio	80	120	96.791	112.905		Lower side	5.319	>0.0001
Ln AUC0→t
difference	−0.463	0.463	−0.039	0.037	100.00	Upper side	−1.141	>0.0001
ratio	80	120	100.384	103.686		Lower side	21.077	>0.0001
LnAUC0→∞
difference	−0.523	0.523	−0.073	0.058	100.00	Upper side	−13.997	>0.0001
ratio	80	120	97.222	102.220		Lower side	−13.612	>0.0001

AUC, area under the curve; C_max, maximum concentration; Ln, log normal.

^*Probability test limits are within equivalence limits.