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What is a Human Mass Balance Study?

Content updated on July 28, 2021 The goal of a human mass balance clinical study is to understand how drugs are absorbed, metabolized, and excreted (AME) after dosing. This information is important because it helps…

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What Is CDISC and What Are CDISC Data Standards?

CDISC stands for the “Clinical Data Interchange Standards Consortium,” and is a global not-for-profit organization that actively develops data standards with the collective knowledge and experience of volunteers within the…

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Common Misconceptions About PBPK Modeling

As Physiologically Based Pharmacokinetic (PBPK) modeling becomes more widely used in regulatory submissions, there are some common misconceptions that have been brought to our attention. We would like to dispel or…

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