Evangeline Rose, University of Maryland, Baltimore County; Kevin E. Omland, University of Maryland, Baltimore County, and Thomas Mathew, University of Maryland, Baltimore County (THE CONVERSATION) A ...

In a test of equivalence, a treatment mean and a reference mean are compared to each other. Equivalence is taken to be the alternative hypothesis, and the null hypothesis is nonequivalence. The model ...

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 ...

Hypothesis of no difference are null hypotheses for studies to show that populations differ. To show that populations are essentially the same, the appropriate null is that substantial differences do ...

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 ...

It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings. Biosimilars go through the same rigorous evaluation of ...