Open AccessA Proton Pump Inhibitor in the Reformulation Setting: Bioequivalence and Potential Implications for Long‐Term Safety
Author(s) -
Dubcenco E,
BeersBlock PM,
Kim LP,
Schotland P,
Levine JG,
McCloskey CA,
Bashaw ED
Publication year - 2017
Publication title -
clinical and translational science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.303
H-Index - 44
eISSN - 1752-8062
pISSN - 1752-8054
DOI - 10.1111/cts.12475
Subject(s) - bioequivalence , food and drug administration , medicine , equivalence (formal languages) , proton pump inhibitor , safety profile , intensive care medicine , term (time) , pharmacology , pharmacokinetics , adverse effect , mathematics , physics , discrete mathematics , quantum mechanics
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.