title: Dissolution comparisons using a Multivariate Statistical Distance (MSD) test and a comparison of various approaches for calculating the measurements of dissolution profile comparison.
abstract: The f2test is generally used for comparing dissolution profiles. In cases of high variability, the f2test is not applicable, and the Multivariate Statistical Distance (MSD) test is frequently proposed as an alternative by the FDA and EMA. The guidelines provide only general recommendations. MSD tests can be performed either on raw data with or without time as a variable or on parameters of models. In addition, data can be limited-as in the case of the f2test-to dissolutions of up to 85% or to all available data. In the context of the present paper, the recommended calculation included all raw dissolution data up to the first point greater than 85% as a variable-without the various times as parameters. The proposed MSD overcomes several drawbacks found in other methods.
authors.affiliation: UFR Pharmacie, Medis, Biopharmaceutical Department, Clermont Auvergne University, 28 Place H. Dunant, BP 38, 63001, Clermont-Ferrand, France. j-michel.cardot@uca.fr.
authors.forename: J-M
authors.initials: JM
authors.lastname: Cardot
authors.affiliation: ESIEE, Cités Descartes, BP 99, 93162, Noisy le Grand Cedex, France.
authors.forename: B
authors.initials: B
authors.lastname: Roudier
authors.affiliation: BEBAC, Neubaugasse 36, 11 1070, Vienna, Austria.
authors.forename: H
authors.initials: H
authors.lastname: Schütz
mesh_terms: D002626:Chemistry, Pharmaceutical; D015999:Multivariate Analysis; D012995:Solubility; D014481:United States; D014486:United States Food and Drug Administration
keywords: MSD; Weibull; dissolution; f 2; multivariate statistical difference