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- W2003286253 abstract "<h2>ABSTRACT:</h2> An analysis of theoretical cumulative mass dissolved-time profile curves represented by Weibull distributions serves to illustrate a dependency of variability in test results of current <i>in vitro</i> dissolution tests, on slope of a profile curve and amount of a cumulative time-shift, at any given point of a dissolution process. As a result of the dependency, a case of high variability can be shown to be an exaggerated reflection of variability in an initial delay in onset of dissolution of a product (due to, e.g., needed dissolution of a gelatin shell or coating, disintegration, and/or wetting etc.), rather than a true reflection of variability of the product in rate of dissolution (subsequent to, e.g., the dissolution of a gelatin shell or coating, disintegration, and/or wetting etc.). The high variability would not be of a clinical significance." @default.
- W2003286253 created "2016-06-24" @default.
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- W2003286253 date "2011-03-01" @default.
- W2003286253 modified "2023-09-25" @default.
- W2003286253 title "COMMENTARY: On Variability in Test Results of Current In Vitro Dissolution Tests" @default.
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- W2003286253 doi "https://doi.org/10.1002/jps.22353" @default.
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