Methods for the Design and Analysis of Replicate‐Experiment Studies to Establish Assay Reproducibility and the Equivalence of Two Potency Assays

Statistical parameters estimated in validation studies to establish the reliability of single-concentration assays, such as the Signal Window and Z'-Factor, are well established. These statistics do not ensure that potency estimates from concentration–response assays will be sufficiently reliable for structure–activity relationship use. The minimum significant ratio (MSR) was proposed as a statistical parameter to estimate the precision of potency estimates from concentration–response assays. This article focuses on the statistical models describing the data generated from biochemical concentration–response assays and the statistical properties of the outcomes. Keywords: parameter estimation; minimum significant ratio (MSR); statistical models; biochemical concentration–response assays