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The is a globally harmonized regulatory document on Drug-Drug Interaction (DDI) studies , finalized in May 2024 and adopted by the FDA in August 2024 . It provides standardized recommendations for designing, conducting, and interpreting in vitro and clinical studies regarding enzyme- or transporter-mediated pharmacokinetic DDIs during drug development. Detailed Content of ICH M12
The is a globally harmonized regulatory document on Drug-Drug Interaction (DDI) studies , finalized in May 2024 and adopted by the FDA in August 2024 . It provides standardized recommendations for designing, conducting, and interpreting in vitro and clinical studies regarding enzyme- or transporter-mediated pharmacokinetic DDIs during drug development. Detailed Content of ICH M12