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A naïve pooled data approach for extrapolation of Phase 0 microdose trials to therapeutic dosing regimens
Microdosing is a strategy to obtain knowledge of human pharmacokinetics prior to Phase I clinical trials. The most frequently used method to extrapolate microdose (≤100 μg) pharmacokinetics to therapeutic doses is based on linear extrapolation from a noncompartmental analysis (NCA) with a two‐fold a...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley and Sons Inc.
2022
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9926085/ https://www.ncbi.nlm.nih.gov/pubmed/36419385 http://dx.doi.org/10.1111/cts.13446 |