Clinical Drug Interaction Studies-Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions and In Vitro Drug Interaction Studies-Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of two final guidances for industry entitled "Clinical Drug Interaction Studies--Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions" and "In Vitro Drug Interaction Studies--Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions." These guidances finalize the draft guidances entitled "Clinical Drug Interaction Studies--Study Design, Data Analysis, and Clinical Implications" and "In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies" published in October 2017. The final guidances are intended to assist drug developers in the planning and evaluation of drug-drug interaction (DDI) potential during drug development and describe a systematic, risk-based approach to the assessment of DDIs.