Application of Regulatory Guidances for Transporter Related DDIs | An ISSX 2021 Short Course

In this short course, participants will learn: 1) the importance of transporters in modulating PK and PD of drugs and their clinical relevance; 2) the evolvement of various decision criteria to predict tDDI from in vitro data including the underlying rationale and limitations; 3) how tDDIs of investigational drugs are evaluated during drug development from real cases; 4) advancements in several areas with active research such as the application of transporter endogenous biomarkers for DDI prediction, the design and implementation of clinical probe drug cocktail studies, and the in vivo assessment of transporter induction; 5) progress in global harmonization of DDI guideline in terms of tDDIs.

Co-chairs: Lei Zhang, Food and Drug Administration, Silver Spring, Maryland, USA and Xiaoyan Chu, Merck & Co., Inc., Rahway, New Jersey, USA

The View from FDA to Assess DDIs Related to Drug Transporters
Xinning Yang, Food and Drug Administration, Silver Spring, Maryland, USA

EMA Regulatory Perspective on Evaluation of Transporter-mediated DDIs
Carolien Versantvoort, Medicines Evaluation Board, Utrecht, The Netherlands

Emerging Translational Approaches to Study Transporter-mediated DDIs and Tissue Exposure
Jashvant Unadkat, University of Washington, Seattle, Washington, USA

In vitro to in vivo Correlations of Transporter Based Drug-Drug Interactions: Learning from IQ Transporter Working Group Data Collection Project
Kate Hillgren, Eli Lilly and Company, Indianapolis, Indiana, USA