Drug-drug interactions: FDA issues guidance on clinical, in vitro studies
The FDA on Thursday finalized two guidances providing recommendations to drugmakers on evaluating potential drug-drug interactions (DDIs) for new drugs through clinical and in vitro testing.
“Together, the two final guidances describe a systematic risk-based approach to evaluation and communication of DDIs,” the FDA writes.
The two guidances finalize draft versions released in 2017 and have been revised to clarify their scope, provide additional considerations for conducting prospective studies and to explain “when DDI studies are needed for drugs identified as transporter substrates from in vitro studies.” Both guidances have been renamed from their draft versions to reflect an emphasis on investigating the cytochrome P450 (CYP) enzyme and transporter-mediated drug interactions.
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