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....

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Main Authors: A. F. Roffel (Author), E.-J. van Hoogdalem (Author)
Formato: Livro
Publicado em: Frontiers Media S.A., 2024-03-01T00:00:00Z.
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