A gamma process modeling approach for the comparison of dissolution profiles.

In this paper, we propose a stochastic gamma process model for assessing the similarity of two dissolution profiles. Based on the proposed stochastic model, we utilize the difference factor and similarity factor to test the similarity of two dissolution profiles based on bootstrap confidence intervals. The performances of the proposed methods are compared with a multivariate test procedure via Monte Carlo simulation studies.

Testing the non-unity of rate ratio under inverse sampling.

Inverse sampling is considered to be a more appropriate sampling scheme than the usual binomial sampling scheme when subjects arrive sequentially, when the underlying response of interest is acute, and when maximum likelihood estimators of some epidemiologic indices are undefined. In this article, we study various statistics for testing non-unity rate ratios in case-control studies under inverse sampling. These include the Wald, unconditional score, likelihood ratio and conditional score statistics.

Statistical analysis of noninferiority trials with a rate ratio in small-sample matched-pair designs.

Testing of noninferiority has become increasingly important in modern medicine as a means of comparing a new test procedure to a currently available test procedure. Asymptotic methods have recently been developed for analyzing noninferiority trials using rate ratios under the matched-pair design. In small samples, however, the performance of these asymptotic methods may not be reliable, and they are not recommended.