Evaluation of Aberrant Observations and Their Impact on Bioequivalence Assessment (U01)

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Aberrant observations in a bioequivalence study with pharmacokinetic endpoints may impact the estimation of residual variability, within-subject variability of the test and reference products, and potentially the bioequivalence conclusion. The purpose of this study is to evaluate and compare different quantitative methods for their capability in defining aberrant observations in bioequivalence studies with different study design features. Study results will advance regulatory science by improving the detection and understanding of aberrant observations and may help generic companies to evaluate the quality and in vivo performance of their proposed products.

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