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Interval Estimation for Ratios in Bioequivalence Trials
Author(s) -
Chen KehWei,
Li Gang,
Sun Yanqing,
Chow SheinChung
Publication year - 1997
Publication title -
biometrical journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.108
H-Index - 63
eISSN - 1521-4036
pISSN - 0323-3847
DOI - 10.1002/bimj.4710390809
Subject(s) - bioequivalence , confidence interval , statistics , mathematics , equivalence (formal languages) , bioavailability , sample size determination , confidence region , uncorrelated , population , variance (accounting) , econometrics , medicine , pharmacology , environmental health , accounting , discrete mathematics , business
Abstract The problem for assessment of equivalence in variability of bioavailability between two drug products is considered. An exact confidence region for the ratio between intrasubject variabilities 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 in variability of bioavailability appears to be asymptotically uncorrelated with the sample mean ratio for average bioavailabilty. As a result, the proposed method in conjunction with the sample mean ratio method can be utilized for assessing population bioequivalence. An example concerning a bioequivalence trial with 24 healthy volunteers is presented to illustrate the proposed method.