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Statistics101 is an Integrated Development Environment (IDE) that uses a simple, powerful language called “Resampling Stats” to develop Monte Carlo programs to analyze and solve statistical problems. The original Resampling Stats language and computer program were developed by Dr. Julian Simon (https://www.juliansimon.com/) and Peter Bruce (https://www.scientificamerican.com/author/peter-bruce/) as a new way to teach Statistics to social science students. Of course, social science students...
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.
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