The application of Phase 0 and microtracer approaches in early clinical development: past, present, and future
Phase 0 microdosing studies were introduced to the drug development community approximately 20 years ago. A microdose is defined as less than 1/100th of the dose calculated based on animal data to yield a pharmacological effect in humans, with a maximum of 100 μg, or 30 nmoles for protein products....
Main Authors: | A. F. Roffel, E.-J. van Hoogdalem |
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Format: | Article |
Language: | English |
Published: |
Frontiers Media S.A.
2024-03-01
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Series: | Frontiers in Pharmacology |
Subjects: | |
Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2024.1369079/full |
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