Advancing Transporter-Based Predictions: Practical Solutions for Toxicity and Drug-Drug Interactions

Advancing Transporter-Based Predictions: Practical Solutions for Toxicity and Drug-Drug Interactions

Brought to you by LGC Standards

Overview

False positives in in vitro toxicology and drug-drug interaction (DDI) studies remain a major bottleneck in drug development, leading to unnecessary clinical trials, inflated costs and delayed access to life saving therapies. However, recent advances in transporter science - including validation of biomarkers like coproporphyrin I (CPI) and next generation in vitro models such as organ on a chip, combined with modelling techniques - are transforming the landscape, enabling more accurate prediction of toxicity and DDI scenarios

This whitepaper explores the latest advances in transporter science and modelling techniques, providing practical guidance for drug developers on integrating biomarker and assay data to improve predictive reliability, in alignment with ICH M12 regulatory guidelines.

Key Objectives:

Explore how transporter biomarkers improve predictive accuracy
Learn how to apply biomarker data in transporter modelling scenarios
Understand how PBPK modelling improves prediction of transporter-mediated drug risks
Align transporter studies with ICH M12 regulatory expectations

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