Are in vitro metabolism and drug-drug interaction studies critical for an investigational new drug application?

Medical research
Watch On Demand

In vitro ADME and drug-drug interaction (DDI) investigations are early activities in the drug development process that are critical for framing downstream decision making. Understanding the ADME properties and DDI risks of your compound helps you avoid unnecessary clinical studies, costs, delays and more.

This webinar will provide insights at a high-level related to regulatory drivers, investigatory objectives, and practical concerns for such studies.  Participants will gain insight into the specific needs and utility for in vitro ADME and DDI investigations in the drug development process.  Regulatory expectations will be reviewed as will points of particular interest for enabling successful achievement of investigatory goals and submissions.

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