A Proton Pump Inhibitor in the Reformulation Setting: Bioequivalence and Potential Implications for Long‐Term Safety. Issue 5 (15th June 2017)

• Record Type: Journal Article
• Authors: Dubcenco, E; Beers‐Block, PM; Kim, LP; Schotland, P; Levine, JG; McCloskey, CA; Bashaw, ED
• Is Part Of: Clinical and translational science. Volume 10:Issue 5(2017)
• Page Start: 387
• Page End: 394
• Publication Date: 2017-06-15
• Subjects: Medicine, Experimental -- Periodicals; Medical innovations -- Periodicals; 616.027
• DOI: 10.1111/cts.12475
• Languages: English
• ISSNs: 1752-8054

Abstract

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.