Why Proactive AME Studies are Critical to Accelerating Your Approval Journey
Conversations in Drug Development Trends
FEBRUARY 21, 2024
Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure. Here are a few of our lessons learned: 1.
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