| Literature DB >> 17365227 |
Abstract
In order to assess the equivalence of two treatments, clinical trials are designed to test against the null hypothesis that the difference (or ratio) of two means (proportions) is either smaller than a pre-specified lower equivalence limit or larger than a pre-specified upper equivalence limit. For example, in generic drug evaluation, such approach is defined as average bioequivalence. However, average equivalence type test is often criticized as lack of the ability to assess the exchangeability of the two treatments. In this article, we restate the statistical hypotheses in the form of stochastic inequalities. The stochastic statement can then be generalized to define the probability of exchangeability (i.e., coverage percentage) of the two treatments. The approach will be illustrated with a numeric example.Mesh:
Substances:
Year: 2007 PMID: 17365227 DOI: 10.1080/10543400601177301
Source DB: PubMed Journal: J Biopharm Stat ISSN: 1054-3406 Impact factor: 1.051