The 2020 FDA guidance for in vitro DDI studies – new things to consider?
4 May 2020
In January 2020, the Final DDI Guidance for Industry was published. Similarly to the draft guidance, there are separate documents for in vitro and clinical drug interaction studies, which are to be used systemically to assess DDI potential. We’ll focus here on conducting in vitro DDI studies according the In Vitro Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance. Read more