Equivalence analyses of dissolution profiles with the Mahalanobis distance

Biometrical Journal. Biometrische Zeitschrift
Thomas Hoffelder

Abstract

For some postapproval changes, the manufacturer has to demonstrate that the dissolution profile of the drug product before the change is statistically equivalent to the dissolution profile after the change. Guidelines suggest the so-called similarity factor f2 as standard approach for the equivalence analysis. f2 is a statistically questionable transformation of the Euclidean distance between both profile means and does not allow a control of the type I error rate. An alternative multivariate distance measure for quantifying the dissimilarity between both profile groups is the Mahalanobis distance. Current equivalence procedures based on the Mahalanobis distance implicate some practical problems in the dissolution context: either one chooses an exact method but the determination of a product independent equivalence margin will not be practically feasible or one chooses an approximate alternative that suffers from the bias of the Mahalanobis distance point estimate. This paper suggests the T2EQ approach for dissolution profile comparisons. T2EQ is a practically feasible equivalence procedure based on the Mahalanobis distance with an internal equivalence margin for comparing dissolution profiles. The equivalence margin is complia...Continue Reading

References

May 10, 2000·Journal of Biopharmaceutical Statistics·M C MaY Tsong
Mar 31, 2005·Journal of Biopharmaceutical Statistics·H Saranadasa, K Krishnamoorthy
Jun 5, 2014·Journal of Biopharmaceutical Statistics·Thomas HoffelderStefan Wellek
Aug 9, 2016·Statistics in Medicine·Shuyan ZhaiYi Huang
Nov 5, 2016·The AAPS Journal·Victor Mangas-SanjuanAlfredo Garcia-Arieta
Nov 21, 2016·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Paulo PaixãoJosé A G Morais
Nov 29, 2017·Statistics in Medicine·Frank BretzMatthias Trampisch
Jan 1, 2017·Therapeutic Innovation & Regulatory Science·Thomas Hoffelder

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Citations

Sep 14, 2019·Biometrics·Kathrin MöllenhoffHolger Dette

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