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 Similarly to the draft guidance, there are separate documents for in vitro and clinical drug interaction studies, which are to be used systemically to assess DDI potential.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
In the cell lab
10 April 2019
A big portion of our in vitro ADME assays are performed using intact cells which have special requirements for assay conditions. To address these requirements these studies are performed in a separate lab dedicated to cell-based work. Why don’t we take a closer look at what goes on in our cell lab?Read more
