DDIs: How to Use Your Predictions to Support Regulatory Submission

Authors: Chapa R, Avvari S
Software: GastroPlus®

Abstract

Identifying potential drug-drug interactions (DDIs) is critical to your program’s success. You need the ability to confidently predict transporter-mediated DDIs and understand how that should impact your regulatory strategy.

In this webinar, you will learn how standard DDI models have been validated in GastroPlus®, as well as how the software can be used to characterize and validate the effect of transporters on drug absorption, systemic distribution, and systemic clearance.

Senior Scientist Revathi Chapa and Scientist II Suvarchala Avvari will be sharing real-life case studies, highlighting how GastroPlus DDI projections have been used in lieu of clinical studies. They’ll walk attendees through the data and reports that can be submitted to support regulatory decision-making, increasing the likelihood of program approval and success.

PRESENTERS: Revathi Chapa, Senior Scientist Suvarchala Avvari, Scientist II

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