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White Paper

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.

Clinical Trials

Clinical Trials Pharmacy Clinical Pharmacology FDA

Analysis Life Sciences Thank You Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon

Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic.

Regulations

Regulations Trials Science Clinical Trials

Drug Discovery Digest

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Analysis Life Sciences Thank You Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon

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