A comparison of four different methods for outlier detection in bioequivalence studies.

Abstract

Bioequivalence studies, required by law whenever a new formulation of an existing drug product is introduced to the market, are designed to test whether the bioavailability, defined as the rate and extent to which a substance reaches systemic circulation, is equivalent for each of two or more formulations. Detection and treatment of outlying data in… (More)

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Cite this paper

@article{Ramsay2005ACO, title={A comparison of four different methods for outlier detection in bioequivalence studies.}, author={Timothy Ramsay and Nasser B Elkum}, journal={Journal of biopharmaceutical statistics}, year={2005}, volume={15 1}, pages={43-52} }