This is the Linux app named PhEq_bootstrap whose latest release can be downloaded as PhEq_boostrap_Windows64.zip. It can be run online in the free hosting provider OnWorks for workstations.
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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
Healthcare Industry, Science/Research, Education
X Window System (X11), Win32 (MS Windows), Qt
This is an application that can also be fetched from https://sourceforge.net/projects/pheqbootstrap/. It has been hosted in OnWorks in order to be run online in an easiest way from one of our free Operative Systems.