FDA Releases Draft Guidances on In Vitro Metabolism and Drug Interactions Studies

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FDA Releases Draft Guidances on In Vitro Metabolism and Drug Interactions Studies

The FDA recently issued two draft guidances for public comment:

  • In Vitro Metabolism and Transporter-Mediated Drug-Drug Interaction Studies
  • Clinical Drug Interactions Studies – Study Design, Data, Analysis, and Clinical Implications

Together, the two draft guidances provide a systemic, risk-based approach to help drug developers evaluate investigational new drugs for potential drug-drug interactions (DDIs) during drug development to inform DDI management strategies. These guidances reflect FDA’s efforts to help drug developers design drug-drug interaction studies that provide meaningful clinical information on how to manage risks when a patient is taking more than one medication. The “In Vitro Metabolism and Transporter-Mediated Drug-Drug Interaction Studies” draft guidance focuses on in vitro experimental approaches for evaluating metabolizing enzyme- and transporter-based drug interaction potential and how to extrapolate in vitro data to decide on the need for clinical DDI studies. The “Clinical Drug Interactions Studies – Study Design, Data, Analysis, and Clinical Implications” draft guidance focuses on clinical studies that evaluate the potential for DDIs and advises sponsors on the timing and design of the clinical studies, interpretation of the results, and options for managing DDIs in patients.  The public comment period for the draft guidance will be open for 90 days. For information on how to submit comments to the public docket, see the notice in the Federal Register.

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