Last updated: Nov. 23, 2022, 6:58 p.m.
Speaker: Dr. Michael Daniel C. Lucagbo
Date: Dec. 1, 2022, 5 p.m.
Venue: via Zoom
Abstract: In vitro dissolution has been shown to be correlated with drug absorption and is often used to assess the equivalence between a test and reference product. In practice, in vitro dissolution profile comparison is often used as a substitute for more costly in vivo bioequivalence studies. Comparison of the dissolution profiles of test and reference products is required by regulatory authorities. Various statistical methods have been developed to assess the equivalence of test profiles. Two of the most widely-used metrics are the difference factor and the similarity factor, denoted in literature as f1 and f2, respectively. In particular, the similarity factor, which was proposed by Moore and Flanner (1996), has generated considerable interest due to its simplicity and has been recommended for dissolution profile comparison by the US Food and Drug Administration (FDA). Regulatory agencies recommend that f2 values greater than 50 may be taken as evidence of equivalence of dissolution profiles. This study reviews some of the current approaches to compare dissolution profiles and develops a methodology to test for similarity between the reference and test profiles under a multivariate normal framework. The accuracy of the methodology shall be evaluated through simulated Type I error rates and powers.
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