Understanding whether two particle size distributions are truly equivalent is a critical step in bioequivalence studies, particularly for complex drug products such as ophthalmic emulsions and inhalation therapies. In this PharmaSUG 2018 white paper, researchers from the University of North Carolina Wilmington and Biostudy Solutions evaluate several statistical methods used to compare distribution data, including Earth Mover's Distance (EMD), Kolmogorov-Smirnov, and Cramér-von Mises metrics.
Using thousands of simulated datasets, the study compares how each method performs when evaluating both equivalent and non-equivalent distributions. The research demonstrates that Earth Mover's Distance is closely related to traditional empirical cumulative distribution function (CDF) methods while offering a practical approach for measuring differences in particle size distributions. The authors also assess how these distance metrics influence in vitro population bioequivalence (IVBE) testing, providing valuable insight into the sensitivity and reliability of each approach.
This research highlights Biostudy Solutions' expertise in biostatistics, simulation modeling, bioequivalence analysis, pharmaceutical data science, and regulatory statistical methodologies. By evaluating emerging FDA-recommended analytical techniques and comparing their real-world performance, the paper helps pharmaceutical and biotechnology organizations make informed decisions about the statistical methods used to support product development and regulatory submissions.
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