A methodology for the comparison of drug dissolution profiles.

The comparison of dissolution profiles is used both during the development and the production of pharmaceutics. However, the question is how to do this comparison correctly. Since actual methods are just qualitative or semi quantitative, a quantitative, statistical or chemometrical approach would be welcome. This is not so easy. Traditional statistical tests do not take into account the multivariate situation. In the literature, some multivariate tests like the Weibull function, cumulative dissolution, similarity factor and Hotelling's T2 test have been described, but each of this methods has its drawbacks and limitations. In this study, also other approaches will be examined like methods based on principal component analysis and methods for longitudinal dat. Following the comparison of the different methods, the advantages and disadvantages will be mentioned. resulting in guidelines indicating which method gives the best result depending on the situtation.