Comparison of free software platforms for the calculation of the 90% confidence interval of f2 similarity factor by bootstrap analysis

2020

Abstract Introduction The calculation of the 90% confidence interval of f2 based on the bootstrap methodology has been proposed and accepted by the main regulatory authorities when the dissolution data shows excessive variability. Different free software platforms allow the calculation of the 90% CI of f2 by means of bootstrapping. Their use in regulatory submissions is growing, but divergent results have been observed between the available software platforms. Therefore, the objective of this work is to analyze the characteristics of these software platforms and evaluate their results. Methods and materials Highly variable in vitro dissolution data from two products were selected. Three dif…