Handling Outliers in Bioequivalence Study Results: Regulatory and Statistical Approaches
Handling Outliers in Bioequivalence Study Results: Regulatory and Statistical Approaches Outlier Management in BA/BE Trials: Statistical Tools and Regulatory Compliance Understanding the Impact of Outliers in Bioequivalence Studies Bioequivalence (BE) studies rely on statistical comparison of pharmacokinetic parameters like Cmax and AUC between test and reference products. However, the presence of outliers—individual data points that…