Evaluation of Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents (ARAs): Study Design, Data Analysis, and Clinical Implications

10 March 2023 – the FDA published the final guidance on the evaluation of gastric pH-dependent drug interactions with ARAs.

This guidance describes the FDA’s recommendations regarding: (1) when clinical DDI studies with ARAs are needed; (2) the design of such clinical DDI studies; (3) how to interpret these study results; and (4) communicating these findings in drug product labeling.

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