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

• 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
• Chủ đề: 1. 60 applied life sciences; 2. Research & experimental medicine

Tóm tắt

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.