A Proton Pump Inhibitor in the Reformulation Setting: Bioequivalence and Potential Implications for Long-Term Safety

E Dubcenco, P M Beers-Block, L P Kim, P Schotland, J G Levine, C A McCloskey, E D Bashaw, E Dubcenco, P M Beers-Block, L P Kim, P Schotland, J G Levine, C A McCloskey, E D Bashaw

Abstract

Proton pump inhibitors (PPIs) have become known for both their therapeutic effect and good safety profile. An application was submitted to the US Food and Drug Administration for approval of a reformulated PPI product that failed bioequivalence testing, but was submitted on the basis of the long history of PPI use as a "surrogate" for equivalence. This review evaluates the safety data for PPIs, discuss variability of pharmacokinetic parameters of PPIs in the reformulation setting, and potential implications of those changes for long-term safety.

© 2017 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Figures

Figure 1
Figure 1
Flow chart diagram of studies selection process to include in the review.
Figure 2
Figure 2
Timeline of the publication appearance in the literature relevant to PPI Formulation Approval.

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