DDI Guidelines

Current ICH Guideline

• ICH M12 Draft – Drug Interaction Studies – 2022

Current FDA DDI and Food Effect Guidance Documents

• Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents – Final 2023
• Drug-Drug Interaction Assessment with Therapeutic Proteins – Final 2023
• Clinical Drug Interactions with Combined Oral Contraceptives – Final 2023
• Clinical Drug Interaction Studies With Combined Oral Contraceptives, Draft November 2020
• Drug Interactions With Acid-Reducing Agents, Draft November 2020
• Drug-Drug Interaction Assessment for Therapeutic Proteins; Draft August 2020
• Clinical DDI Studies 2020
• In Vitro DDI Studies 2020
• Food Effects – Clinical Pharmacology Considerations – Draft 2019

Current EMA DDI Guideline

• EMA DDI Guideline (corr. 2) 2012
• EMA DDI Guideline – Overview of Comments

Current Japanese (PMDA) DDI Guideline

• PMDA DDI Guideline 2018