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 ...

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 ...

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 ...

Visit NAP.edu/10766 to get more information about this book, to buy it in print, or to download it as a free PDF. Descriptions of student or adult competency in a particular subject area, usually ...

In-house harmonization of excipient specifications ensures compliance with multiple pharmacopoeias, reducing redundant testing and aligning with global regulatory expectations. Specification ...