Transporters play a critical role in drug absorption, distribution, and elimination, and their involvement in drug-drug interactions (DDIs) can lead to altered drug concentrations and unexpected adverse effects that hamper the effectiveness of the treatment. Significant advancements were seen in the area of PBPK applications in metabolic DDIs to inform program development and regulatory decision making, and the paradigm is slowly shifting towards transporters, thereby increasing the emphasis on the utility of PBPK models to predict the transporter-based DDIs. Transporter-mediated drug-drug interactions (DDIs) present unique challenges in drug development and clinical management, often complicating the prediction and understanding of pharmacokinetic profiles.

In this presentation, Drs. Revathi Chapa (Senior Scientist, PBPK Solutions), Suvarchala Avvari (Scientist II, PBPK Solutions), and Susie Zhang (Vice President, Regulatory Strategies), will explore the complexities of transporter-mediated DDIs, highlighting cross-validation of multiple compounds for assessing and predicting their risk.

Attendees will learn…

1) About regulatory guidance’s specific to transporter-mediated DDIs

2) How to apply and interpret decision trees in evaluating transporter-mediated DDIs

3) About the recent development in applying biomarkers (endogenous substrates) for transporter-mediated DDI evaluation

4) Insights into state-of-the-art tools, including in vitro assays, computational models, and clinical data integration, to better evaluate transporter interactions.

5) The importance of high-quality DDI standard models and reports in providing validated, regulatory-aligned solutions

By mastering these techniques, participants will be equipped to navigate the challenges of transporter-mediated DDIs and make more informed decisions in drug development and therapeutic management.

Interactive Q&A Session Have questions? Ask your question live or submit them for a follow-up discussion.