2017
DOI: 10.1248/bpb.b16-00904
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Comparison of Dissolution Similarity Assessment Methods for Products with Large Variations: <i>f</i><sub>2</sub> Statistics and Model-Independent Multivariate Confidence Region Procedure for Dissolution Profiles of Multiple Oral Products

Abstract: 2 statistics defined in the MHLW guidelines (MHLW f 2 method) and two different Method B procedures, including a bootstrap method applied with f 2 statistics (BS method) and a multivariate analysis method using the Mahalanobis distance (MV method). The MHLW f 2 and BS methods provided similar dissolution similarities between reference and generic products. Although a small difference in the similarity assessment may be due to the decrease in the lower confidence interval for expected f 2 values derived from th… Show more

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Cited by 13 publications
(8 citation statements)
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“…Furthermore, there are 2 recent papers comparing different methods for the investigation of bioequivalence of dissolution profiles. For instance, Yoshida et al compared the f 2 , a model‐independent multivariate confidence region procedure and the f 2 bootstrapping method, showing that all these approaches could lead to different conclusions on the same datasets. Moreover, Paixão et al analysed the properties of the f 2 , the multivariate statistical distance, and f 2 bootstrapping methods in situations where the f 2 was not applicable because of high variability in the dissolution data.…”
Section: Introductionmentioning
confidence: 99%
See 1 more Smart Citation
“…Furthermore, there are 2 recent papers comparing different methods for the investigation of bioequivalence of dissolution profiles. For instance, Yoshida et al compared the f 2 , a model‐independent multivariate confidence region procedure and the f 2 bootstrapping method, showing that all these approaches could lead to different conclusions on the same datasets. Moreover, Paixão et al analysed the properties of the f 2 , the multivariate statistical distance, and f 2 bootstrapping methods in situations where the f 2 was not applicable because of high variability in the dissolution data.…”
Section: Introductionmentioning
confidence: 99%
“…4 Not more than 1 mean value of >85% dissolved for any of the formulations. 5 The relative standard deviation or coefficient of variation, that is, the ratio of the standard deviation to the sample mean, should be less than 20% for the first point and less than 10% from second to last time point for any product. It is computed across units at each time point independently in both groups.…”
mentioning
confidence: 99%
“…The average elution rate of each sample was compared to the sample formulated on day 0. The similarity of dissolution profiles was evaluated using the f2 statistic defined in the Ministry of Health, Labor, and Welfare guidelines [ 23 ].…”
Section: Methodsmentioning
confidence: 99%
“…Also, this effect has been found in many works like that obtained by Mansouri and co-researchers, as in the preparation of ibuprofen formulation as nanoparticles using solvent: anti solvent method [25] . The difference factor of f1 and similarity factor of f2 have been widely used for dissolution profile comparison [26,27,28] . They were calculated to compare the dissolution profiles of pure, physical mixture, nano incorporated tablet in each media as shown in table (5).…”
Section: Differential Scanning Calorimetry (Dsc)mentioning
confidence: 99%