Abstract
Dissolution profile comparsions can be done by virtue of the similarity factor . It is a logarithmic reciprocal square root transformation of the sum of squared error of % dissolution differences between two profiles at several time points. It gives information on the degree of similarity between the two profiles: An value between 50 and 100 suggests the similarity/equivalence of the two dissolution curves being compared. The objective of this report was to provide a careful examination on the metrics in detail. It was shown that values exceeded 50, when relative differences in % dissolved between two products were less than 15% at all time points. The similarity factor value was also found to be greater than 50, in cases when absolute % dissolution differences were below 10% at all time points. Interestingly, the value was changed by the number of the time points selected for calculation. In particular, tended to have higher values, when the metrics used a large number of time points in which % dissolved reached plateau. Finally, since the similarity factor was a sample statistics, it was impossible to infer type I/II errors and sampling error. Despite certain limitations inherited in the metrics, it was easy and convenient to evaluate how similar the two dissolution profiles were.
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