The adequacy of the Mahalanobis distance to assess the comparability of drug dissolution profiles - Scientific guideline

The aim of this question-and-answer document is to provide clarification about the suitability of the Mahalanobis distance as a tool to assess the comparability of drug dissolution profiles and to a larger extent to emphasise the importance of confidence intervals to quantify the uncertainty around the point estimate of the chosen metric (e.g. the f2 factor or the Mahalanobis distance).

Keywords: Bioequivalence, dissolution profiles, f2, Mahalanobis distance, biowaiver

Current version

Question and answer on the adequacy of the Mahalanobis distance to assess the comparability of drug dissolution profiles

Reference Number: EMA/810713/2017