What question did this study set out to answer?

To resolve theoretical and practical issues in bioequivalence testing by applying intersection-union tests and correcting misconceptions about equivalence confidence sets.

November 1, 1996Statistical ScienceOpen Access

Bioequivalence trials, intersection-union tests and equivalence confidence sets

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To resolve theoretical and practical issues in bioequivalence testing by applying intersection-union tests and correcting misconceptions about equivalence confidence sets.
Mathematical and statistical derivation of equivalence tests using the intersection-union principle.
Theoretical comparison of parameter ratio formulations against parameter difference formulations.
Construction of exact 100(1 - alpha)% confidence sets that directly correspond to size-alpha equivalence tests, extended to multiparameter problems.
Derived a statistical test with greater statistical power than the standard tests specified in FDA and European Community regulatory guidelines.
Refuted the assertion that defining bioequivalence in terms of parameter ratios is inherently more difficult than using parameter differences.
Demonstrated that the conventional assumption linking size-alpha tests to 100(1 - 2alpha)% confidence sets leads to incorrect statistical practices and provided valid 100(1 - alpha)% construction methods.

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Implication

Methodological analysis demonstrates improved statistical power over standard regulatory guidelines for bioequivalence, indicating more accurate generic drug evaluation.

Cite This Study

Berger et al. (1996) studied this question.

synapsesocial.com/papers/69da8e0ba6045d71bfa3d14a https://doi.org/10.1214/ss/1032280304

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Implication

Methodological analysis demonstrates improved statistical power over standard regulatory guidelines for bioequivalence, indicating more accurate generic drug evaluation.

Bioequivalence trials, intersection-union tests and equivalence confidence sets

Key Points

Discussion

Implication

Cite This Study

Bioequivalence trials, intersection-union tests and equivalence confidence sets

Key Points

Discussion

Implication

Cite This Study

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