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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.

TORONTO (PRWEB)
August 25, 2020

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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