A Comparison of FDA, EMA & PMDA Regulatory Guidance for In Vitro Drug-Drug Interaction (DDI) Assessments, Upcoming Webinar Hosted by Xtalks

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In this free webinar, the featured speaker will discuss the basic in vitro tests (CYP and transporter models) required today for regulatory compliance in this area. Attendees will understand the approaches now used to generate the data required, how it is processed and the potential implications if certain DDI parameters (R values) are triggered.

Xtalks Life Science Webinars

Drug-drug interaction status for a molecule can be of great importance – for example, a high drug-drug interaction status as a victim drug (high fraction metabolized, small therapeutic window) is at risk of restrictive labeling and even non-approval.

Join David Wilkinson, Principal Study Director, Metabolism, Covance in a live webinar on Thursday, September 10, 2020 at 10am EDT (3pm BST/UK).

Assessment of drug-drug interactions is an increasingly important component of drug development to help ensure safe efficacious medicines. Since 1997, the regulatory agencies FDA, EMA and PMDA have endorsed the use of in vitro metabolism studies to assess the DDI potential of new chemical entities (NCE). Over the past 10 years, however, scientific progress has been rapid, fueled by sophisticated in vitro models and in silico predictive programs.

To reflect this scientific progress, the FDA, EMA and Japan’s MHLW (PMDA) have issued updated guidance/guidelines outlining what in vitro data should be obtained, mainly focused on CYP enzymes and drug transporters, and how this should be processed with possible consequences for potential clinical assessment and product labeling. This webinar will review and compare these three regional guidelines for testing new chemical entities for their potential drug-drug interactions.

Drug-drug interaction status for a molecule can be of great importance – for example, a high drug-drug interaction status as a victim drug (high fraction metabolized, small therapeutic window) is at risk of restrictive labeling and even non-approval.

For more information or to register for this event, visit A Comparison of FDA, EMA & PMDA Regulatory Guidance for In Vitro Drug-Drug Interaction (DDI) Assessments.

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Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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Sydney Perelmutter
Xtalks
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