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Showing 2 open source projects for "batch"
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PhEq_bootstrap
FDA's f2 computation with bootstrap technique
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. ... -
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