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Update on FDA's Final Drug-Drug Interaction Guidance - Non-Member Registration
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Update on FDA's Final Drug-Drug Interaction Guidance - Non-Member Registration

Evaluating drug-drug interaction (DDI) risk is a critical aspect of the risk assessment of new drugs prior to market approval and during the post-marketing period. DDIs can occur when a co-administered drug alters the pharmacokinetics of another drug. The resulted changes could cause reduced efficacy or increased side effects for the affected drug. Such consequences underscore the relevance of evaluating DDI during drug development.

6/30/2020
When: June 30, 2020
11:00 am ET
Where: Online Webinar


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Evaluating drug-drug interaction (DDI) risk is a critical aspect of the risk assessment of new drugs prior to market approval and during the post-marketing period. DDIs can occur when a co-administered drug alters the pharmacokinetics of another drug. The resulted changes could cause reduced efficacy or increased side effects for the affected drug. Such consequences underscore the relevance of evaluating DDI during drug development. DDI assessment usually starts with in vitro evaluation which help define the potential for in vivo interactions and determine when and which clinical DDI assessment is needed.

The US Food and Drug Administration (FDA) has recently revised the 2017 draft guidance on in vitro and Clinical DDI evaluations and released the final versions this January. The changes were mainly implemented in the in vitro DDI guidance, including evaluating CYP induction potential of an investigational drug, predicting transporter inhibition risk in vivo, situations where assessment of metabolite DDI potential may be relevant, and certain considerations for in vitro experiment methodology. This webinar aims to provide an opportunity for the audience to learn the rationale underlying those updates and to understand the remaining knowledge gaps that warrant further research to address.

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