A Proton Pump Inhibitor in the Reformulation Setting [electronic resource] : Bioequivalence and Potential Implications for Long-Term Safety Reformulation and the Long-Term Safety of PPIs

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Tác giả:

Ngôn ngữ: eng

Ký hiệu phân loại: 610 Medicine and health

Thông tin xuất bản: Washington, D.C. : Oak Ridge, Tenn. : United States. Dept. of Energy. Office of Science ; Distributed by the Office of Scientific and Technical Information, U.S. Dept. of Energy, 2017

Mô tả vật lý: Size: p. 387-394 : , digital, PDF file.

Bộ sưu tập: Metadata

ID: 260480

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.
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