AAPS eChalk Talk | Beyond Probe Drugs: Biomarker-Based Assessment of CYP3A Drug-Drug Interaction Risk

Beyond Probe Drugs: Biomarker-Based Assessment of CYP3A Drug-Drug Interaction Risk

The CYP3A gene locus encodes several monooxygenase enzymes responsible for 30-40% of the enzymes expressed in the human liver and intestine, contributing to the metabolism and elimination of roughly half of all marketed drugs. Exploring the potential for inhibition or induction of this family of enzymes is of particular interest for drugs early on in clinical development.

A high through-put LC-MS/MS assay was developed by Alturas Analytics that simultaneously quantifies three endogenous biomarkers of CYP3A inhibition and induction in human plasma. Aligned with ICH M12 principles, the biomarker approach offers a probe-free, cost-effective method for assessing drug-drug interaction potential alongside clinical pharmacokinetic studies. Method optimization and qualification considerations including sensitivity, stability, matrix variability, and biological effects will be discussed.

Presented by Sarah Oehm, PhD, Senior Scientist
Moderated by Katherine Yahvah, PhD, Laboratory Director

Wednesday, October 14, 2026
1:15 PM ET

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