Dissolution Profile Comparison: Statistical Methods

Authored by: Harry Yang

Encyclopedia of Biopharmaceutical Statistics

Print publication date:  August  2018
Online publication date:  August  2018

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:

10.1201/9781351110273-140000056

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Abstract

In vitro dissolution testing is a critical analytical methodology used for monitoring product quality and assessing performance characteristics after scale up and post-approval changes. In this article we review published statistical work on dissolution profile comparison and related regulatory requirements. A Bayesian approach that overcomes many of the statistical issues of the current methods such as f 2 statistic is described in detail.

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