Updates on FDA’s Drug-Drug Interaction Final Guidances

Kellie Reynolds and Xinning Yang from CDER’s Office of Clinical Pharmacology discuss two FDA final guidances that provide a systemic approach to the evaluate the drug-drug interaction (DDI) potential of investigational drugs and describe how the approach can be implemented. The two final guidances are In Vitro Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions and Clinical Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions.

Learn more at https://www.fda.gov/drugs/news-events...
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