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The FDA recently approved updated regulatory guidance for drug-drug interactions (DDIs). This webinar will focus on how to follow the FDA guidance, design in vitro studies, interpret the data and assess potential drug-drug interactions, using both static and Physiologically Based Pharmacokinetic (PBPK) models.
We will also share our interpretations, as regulatory agencies recommend different approaches for calculation of the DDI potentials including static and PBPK models.
Co-administration of multiple drugs may potentially cause a drug-drug interaction (DDI) in which one drug alters the exposure of another, resulting in either therapeutic failure or risk of a patient’s life. In vitro studies are key to assessing potential DDIs because they are cost-effective, time-saving and can help to understand the mechanisms of DDI and provide directives to clinical trials (clinical trials should not be used to screen potential DDIs because of high costs, lengthy duration and ethical considerations, but they should be used to confirm potential DDIs recommended from in vitro studies and corresponding modeling).
Join this informative webinar on static & PBPK modelling to assess potential DDIs.
Source : Event Website
In this webinar, attendees will learn about:
Source : Event Website
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