6533b82afe1ef96bd128ca21
RESEARCH PRODUCT
Basing the Analysis of Comparative Bioavailability Trials on an Individualized Statistical Definition of Equivalence
Stefan Welleksubject
Statistics and Probabilityeducation.field_of_studyAlternative hypothesisGaussianPopulationGeneral MedicineExpected valueBioequivalenceBioavailabilitysymbols.namesakeCalculussymbolsStatistics Probability and UncertaintyeducationEquivalence (measure theory)MathematicsParametric statisticsdescription
The conventional definition of bioequivalence in terms of population means only, is criticized for lacking relevance to the individual subject. Both approaches to bioequivalence assessment proposed here for avoiding this shortcoming, focus on the probability of an event induced by the response of a randomly selected subject to two formulations of a given active agent. The first approach leads to converting the basic idea underlying the well-known 75-rule into an exact statistical procedure. The second approach is of a parametric nature. It reduces bioequivalence assessment to testing against the alternative hypothesis that the standardized expected value of a Gaussian distribution is contained in a short interval around zero. For this problem, an exact optimal solution is provided as well.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 1993-01-01 | Biometrical Journal |