Confidence region approach for assessing bioequivalence and biosimilarity accounting for heterogeneity of variability
Summary: For approval of generic drugs, the FDA requires that evidence of bioequivalence in average bioequivalence in terms of drug absorption be provided through the conduct of a bioequivalence study. A test product is said to be average bioequivalent to a reference (innovative) product if the 90\% confidence interval of the ratio of means (after log-transformation) is totally within (80\%, 125\%). This approach is considered a one-parameter approach, which does not account for possible heterogeneity of variability between drug products. In this paper, we study a two-parameter approach (i.e., confidence region approach) for assessing bioequivalence, which can also be applied to assessing biosimilarity of biosimilar products. The proposed confidence region approach is compared with the traditional one-parameter approach both theoretically and numerically (i.e., simulation study) for finite sample performance.
- A Confidence Region Approach for Assessing Equivalence in Variability of Bioavailability
- An alternative definition of individual bioequivalence
- Bioequivalence trials, intersection-union tests and equivalence confidence sets. With comments and a rejoinder by the authors
- Interval Estimation for Ratios in Bioequivalence Trials
- The multivariate assessment of bioequivalence
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