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What is FDA’s stand on statistical outlier? Is it essential to fulfill BE criteria with and without inclusion of the statistical outlier?

April 26, 2017criteria Essential fda fulfill outlier stand statistical

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What is FDA’s stand on statistical outlier? Is it essential to fulfill BE criteria with and without inclusion of the statistical outlier?

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BALA: FDA: ” Deletion of outlier values is generally discouraged, particularly for nonreplicated designs. … Sponsors or applicants with these type of data sets may wish to review how to handle outliers with appropriate review staff”. I would think a nonparametric approach might be acceptable.