FDA Draft Guidance Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents

The draft guidance newly released by FDA on “Evaluation go Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications” is now available in DIDB Resource Center. Please note that you must be signed in to access.

This draft guidance describes FDA’s recommendations regarding: (1) when clinical DDI studies with acid-reducing agents are needed; (2) the design of clinical DDI studies; (3) how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

DIDB contains absorption-based drug interaction data. The study results are presented based on the underlying mechanism. For example, there are about 450 entries on pH-dependent drugs interactions in DIDB curated from literature and NDA reviews with detailed information about PK assessment results, study design, population, formulation, dosing, and safety results