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

Autor:	E, Dubcenco, P M, Beers-Block, L P, Kim, P, Schotland, J G, Levine, C A, McCloskey, E D, Bashaw
Rok vydání:	2017
Předmět:	Fractures Bone Time Factors Therapeutic Equivalency Research Publications Adverse Drug Reaction Reporting Systems Humans Proton Pump Inhibitors Articles Drug Approval Article
Zdroj:	Clinical and Translational Science
ISSN:	1752-8062
Popis:	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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=pmid________::5a7c82c239ac87250fd042d85094a721 https://pubmed.ncbi.nlm.nih.gov/28618191 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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