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Update on FDA's Final Drug-Drug Interaction Guidance
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ISSX Webinar Series

   

 

 

Abstract:

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The US Food and Drug Administration (FDA) has recently revised the 2017 draft guidance on in vitro and Clinical DDI evaluations and released the final versions this January.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.

About the Speaker:

Dr. Xinning Yang is a Policy Lead in Guidance & Policy team (GPT) under the Office of Clinical Pharmacology (OCP), CDER of FDA. He received his Ph.D. in Pharmaceutical Science from University at Buffalo, mentored by Dr. Marilyn Morris. In the past, as a clinical pharmacology reviewer, he reviewed a number of IND/NDA submissions contributing to the benefit/risk assessment of neurology drug products. His current primary focus is guidance and policy development and implementation in various areas, focusing on drug metabolism, pharmacokinetics, and drug-drug interactions related Clinical Pharmacology issues. He is active in research and led or co-led multiple research projects funded internally. He served as the Chair of Transporter Scientific Interest Group of OCP from 2014 to 2015. He has received a number of individual and team awards from CDER which recognized his contribution to regulatory science and research. He is the Co-Chair of Transporter Focus Group of ISSX and a member of International Transporter Consortium (ITC) committee. He is participating in the International Council Harmonization (ICH) M12 DDI guidance working group. He has been an invited speaker for multiple conferences and workshops and organized symposia at several meetings.

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