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Drug-Drug Interaction Studies


Drug-Drug interactions (i.e., interactions between an investigational drug and other drugs administered to subjects/patients) must be evaluated during drug development for small molecules and biologics. Pharmacokinetic evaluation of drug-drug interactions via nonclinical and clinical studies can help determine if interactions between concomitantly administered drugs exist and if such interactions require a dosage adjustment or other measures to reduce risk to the target patient population. Drug-Drug interaction studies may evaluate the enzymes (CYP P450) and transporters involved in the drug’s metabolism and elimination or may investigate a potential interaction with other common concomitant medications administered in the target patient population.

When to Execute DDI Studies in Development Programs

Executing drug-drug interaction studies can be done throughout all phases of drug development and there are many considerations that go into when and how to conduct nonclinical and clinical drug interaction studies.

Learn more by reading FDA’s Guidance “Drug Interaction Studies — Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations.”