2023-05067: Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications; Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications." This guidance focuses on specific recommendations pertinent to pH-dependent drug-drug interaction (DDI) assessment and describes the current recommendations of FDA regarding when clinical DDI studies with acid-reducing agents (ARAs) are needed, design of the clinical studies, interpretation of study results, and options for managing pH-dependent DDIs in patients. This guidance finalizes the draft guidance of the same title issued on December 1, 2020.
The agency’s own summary, as published.
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