Generics R&D - OSD- Dissolution Similarity and difference factors

As confirmation of acceptance of each formulation of the test product, difference (f1) & similarity (f2) factors should be determined by performing the requisite dissolution rate testing on 12 units of each

The difference factor is measurement of relative error between the curves, whereas the similarity factor is a measurement of the similarity in the percent (%) dissolution between the two curves. If the f1 values range between 0 and 15 and f2 values range between 50 and 100 the dissolution curves being compared are considered similar or equivalent

The closer f1 and f2 are to 0 and 100, respectively, the better the comparability of the curves

Calculated f1 and f2 for this formulation relative of product A indicate that Product A 100 rpm is closer compared to Product A 75 rpm and similarly Product B 75 rpm is closer to product B