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

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PDF iconQuestions and answers

Reference numberEMA/810713/2017
Published19/09/2018
KeywordsBioequivalence, dissolution profiles, f2, Mahalanobis distance, biowaiver
DescriptionThe 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).

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