EMA issues new guideline on assessing gastrointestinal drug interaction risks
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The European Medicines Agency has released a guideline that outlines how to evaluate drug interactions that occur in the gastrointestinal (GI) tract.
The document focuses on extrinsic factors such as food, other medicines, or formulation components that can alter the way a drug is absorbed in the gut, and it provides recommendations for study designs and data interpretation.
The guidance is intended to help developers and regulators better predict and manage GI-related interaction risks, potentially streamlining development programs and regulatory submissions.
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This writeup was produced by pharmadog from original reporting by raps.
Original headline: “EMA guideline addresses concerns with potential drug interactions in the GI tract”
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