Abstract
This article presents a short review on guidelines for dissolution profile testing, particu-larly 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 per-formed in different ways. There are many model-dependent and model-independent proce-dures suggested in the methodical literature. Current guidelines primarily recommend the application of a method based upon the f 2 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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Freitag, G. Guidelines on Dissolution Profile Comparison. Ther Innov Regul Sci 35, 865–874 (2001). https://doi.org/10.1177/009286150103500325
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DOI: https://doi.org/10.1177/009286150103500325