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Keith D. Gallicano
Scientists Advancing Affordable Medicines, USA
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Brief Report
Use of Reverse Blood Grouping to Identify Plasma Samples Switched between Subjects in a Pharmacokinetic Study
Author(s): Sandeep Shah, Hiren Mehta, Charles E. DiLiberti and Keith D. Gallicano*
Background: Inadvertent switching of plasma samples between two subjects is a leading cause of implausible pharmacokinetic profiles in bioequivalence studies, and may cause erroneous bioequivalence conclusions. Such events typically go unnoticed until review of the pharmacokinetic data. A key objective was to find an in vitro test that, in lieu of real-time documentation, and independent of the drug plasma concentrations themselves, could provide definitive evidence of such a putative sample swap. Methods: We present a case of a post-hoc analysis of two plasma samples from a bioequivalence study using a Reverse Blood Grouping (RBG) procedure to demonstrate unequivocally that a sample switch had occurred between two study subjects with different ABO blood types. Results: The bioequivalence study failed with.. View more»