Among the first decisions to be made when initiating a composites testing program is the selection of test methods to follow. Unless performing highly customized testing, it’s usually not difficult to ...

Equivalence and interval tests for Lehmann's alternative that extend the well-known Savage test for one-sided hypotheses are proposed. The proposed tests are shown to be unbiased with a strictly ...

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA ...