Equivalence Testing: The modern approach to testing your assay
Since the disadvantages of hypothesis testing are well known, Chapter <1032> of the US Pharmacopoeia recommends to use equivalence testing for determining your sample similarity. However, overall adaption of equivalence testing is still relatively low. Partially, this might be explained by the fact that this method isn't as ready-to-use as hypothesis testing. Hypothesis testing only requires choosing an adequate confidence level. In contrast, to perform effective equivalence testing it is not only necessary to determine suitable measures of similarity but also to determine the margins against which these measures are tested. The USP states:
"The challenge in implementing equivalence testing is setting appropriate equivalence bounds for the nonsimilarity measures"
Usually, these measures of similarity and their margins are developed from historical data, but manually collecting and processing all the relevant parameters is cumbersome and prone to errors. PLA 3.0 already stores your historical data in the documents on your database. With PLA 3.0 you can start developing your margins right away.