In vitro drug transporter data is critical for understanding drug-drug interaction potential, but this data is only useful if conclusions can be drawn. Researchers are confronted with practical challenges associated with compounds that are unstable, sticky or insoluble, resulting in convoluted or inconclusive results.
Three interesting transporter case studies will be presented, each highlighting a creative solution to explore perplexing initial results and generate useful data, despite problematic physicochemical characteristics of the drugs involved. Dr. Barbara will also discuss current regulatory expectations for drug transport evaluations, including details from the draft global ICH M12 Drug Interaction Studies Guideline, scheduled to be finalized and implemented by regulatory agencies around the world in 2024.
Key Learning Objectives:
- Fundamental test system and platform limitations in drug transporter research
- Practical methodologies to account for nonspecific binding and instability in transporter studies
- Study designs with case studies
Who Should Attend:
- Research scientists and drug development leadership aiming for successful IND / NDA submission, needing to meet regulatory requests and expectations, desiring to formulate a development plan that mitigates risks of late-stage failure, or simply wanting to better understand the ADME properties and potential DDI risks of their compound.