Journal of Biopharmaceutical Statistics · 2005 · 42 citations · 14 references
PharmacyBiostatisticsDissolution TestingDosage Form DesignForensic Pharmaceutical AnalysisDissolution MediaDrug DissolutionApproximately Unbiased TestF2 Similarity TestingMultivariate Dissolution Analysis
ABSTRACT A multivariate test of size α for assessing the similarity of two dissolution profiles is proposed. The inferential procedure is developed by using the approach for the common mean problem in a multivariate setup due to Halperin (1961 Halperin , M. ( 1961 ). Almost linearly-optimum combination of unbiased estimates . Journal of the American Statistical Association 56 : 36 – 43 .[Taylor & Francis Online], [Web of Science ®] , [Google Scholar]). The performance of the proposed method is compared with Intersection Union Test as well as f 2 criterion recommended by the FDA through a simulation study. All the methods are illustrated with real examples.
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Mathematical comparison of dissolution profiles
J. W. Moore, Henry H. Flanner · Pharmaceutical technology · 1996 · 1.1K citations