PhEq_bootstrap: Open-source software for the simulation of f2 distribution in cases of large variability in dissolution profiles

Abstract

PhEq_bootstrap is a free software tool that uses the similarity factor (f2) to assess dissolution profile similarity in cases of large data variability. Its theoretical background is founded on bootstrapping, a statistical technique used to simulate the distribution of f2 values based on the available sample. It allows both justification of profile similarity and prospective simulations for the establishment of the formulation development endpoint. The software is FOSS (free open-source software) and is available online (1).