Table II.

Summary BE Statistics for Two HV Generic Drugs, Analyzed Using RSABE or Unscaled ABE, Depending upon the Value of s _WR

Summary of statistical analysis-scaled data: least-square geometric means, point estimates and 90% confidence intervals
Parameter	T/R ratio	Lower 90% CL	Upper 90% CL		s WR	Criteria bound	Method used	Outcome
Drug A: fed bioequivalence study, N = 43
AUC0 − t	1.17	93.91	132.91	0.5723	0.7565	−0.2892	Scaled/PE	Pass
AUC∞	1.11	94.64	124.91	0.3452	0.5875	−0.1767	Scaled/PE	Pass
C max	1.19	100.47	133.26	0.3768	0.6138	−0.1684	Scaled/PE	Pass
Drug B: fasting bioequivalence study, N = 36
AUC0 − t	0.99	89.82	109.53	0.07425	0.2725	−0.03914	Unscaled	Pass
AUC∞	1.02	92.57	111.77	0.06561	0.2561	−0.03126	Unscaled	Pass
C max	0.98	85.70	110.54	0.1069	0.3270	−0.05294	Scaled	Pass