A confidence region approach for assessing equivalence in variability of bioavailability

The problem for assessment of equivalence in variability of bioavailability between two drug products is considered. Similar to the method for assessing bioequivalence in average bioavailability proposed by CHOW and SHAO (1990), an exact confidence region approach is derived when the intersubject variance is known. When the intersubject variance is unknown, a large sample approximation is considered. The proposed method for assessing equivalence of variability of bioavailability appears to be asymptotically uncorrelated with that of CHOW and SHAO (1990) for average bioavailability. As a result, the proposed method in conjunction with the method proposed by CHOW and SHAO (1990) constitutes a confidence region approach for assessing population bioequivalence. An example concerning a bioequivalence trial with 24 healthy volunteers is provided to illustrate the proposed method.

Duke Scholars

Author Shein-Chung Chow Biostatistics & Bioinformatics, Division of Biostatistics