This article presents a short review on guidelines for dissolution profile testing, particularly focusing on the recommendations regarding statistical methods for assessing profile similarity. In this context, the guidelines on in vitro/in vivo correlations and on granting biowaivers are outlined briefly. The comparison of two dissolution profiles can be performed in different ways. There are many model-dependent and model-independent procedures suggested in the methodical literature. Current guidelines primarily recommend the application of a method based upon the f2 statistic as a measure of the similarity of two dissolution curves, though this procedure has often been criticized recently. The goal of this article is to give a survey of the current guidelines, including a description and discussion of the recommended methods for data analysis.
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