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Drug-Drug Interactions with Acid-Reducing Agents

PRESENTED TO: ASCPT 2025 by BioPharma Services
PRESENTED BY:  M. Ngoc Le

PURPOSE

Acid-reducing agents (ARAs), including widely used proton pump inhibitors (PPIs), can significantly alter the absorption and efficacy of oral medications by increasing gastric pH. With the FDA’s 2023 guidance emphasizing the need to evaluate pH-dependent drug-drug interactions (DDIs) early in development, this poster analyzes how recent approvals have addressed these interactions. By reviewing FDA approval packages from 2021 to 2024, this work offers insights into the evolving regulatory landscape and practical approaches—such as DDI studies, dissolution profiles, and population PK modeling—for mitigating ARA-related risks in drug development.

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