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Abstract:
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Statistical equivalence testing is used in the biopharmaceutical industry to support method transfer, method remediation, and process comparability. In this study, equivalence testing is used to demonstrate that two orthogonal methods, size exclusion (SE) chromatography and sedimentation velocity analytical ultracentrifugation (SV-AUC), are similarly capable of detecting/quantifying protein aggregates (i.e., that they respond equivalently to changes in the amount of analyte). The two techniques were run side-by-side on samples containing protein aggregates spiked in at six different levels. In this paper, we compare definitions of equivalence based on both the ratio and difference of slopes. Methods for determining definitions of equivalence are proposed and discussed. The ratio and difference methods are compared, and recommendations for selecting an appropriate method are provided.
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