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n contained in patient safety data, which can enhance the evaluation and the use of this information over time. The Canadian guideline on bioequivalence allows identification of outliers through for example studentized residuals, and it explicitly accepts exclusion of subject data when their studentized residuals reach a certain magnitude. The guideline also requires that the type I errors (patient's risk, chance of declaring bioequivalence for a bioinequivalent product) be maintained at the 5% level. This manuscript investigates if the outlier re
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