This program was developed as a help in establishing pharmaceutical equivalence by use of FDA f2 coefficient. It was designed to help with f2 computation in cases when intra- and inter-batch variability is large, namely RSD>10%. The use of statistical bootstrap technique allows to implement confidence interval (CI) into the f2 coefficients resulting in overcoming of their major drawback in the original metrics. The algorithm provides possible “worst case scenario” of f2 values, thus supporting claim about pharmaceutical equivalence. The target users are researchers from industry and academia dealing with pharmaceutical equivalence problem.
The software is Open Source. It was developed in Lazarus environment, therefore source code is available in ObjectPascal.
- automatic computation of f1 and f2 based on the individual drug dissolution profiles
- bootstrapping used for estimation of f1/f2 distribution
- full report of the whole computational process
- graphical representation of the profiles
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