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...

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Detalles Bibliográficos
Autores principales: van der Heijden, Lisa, van Nuland, Merel, Beijnen, Jos, Huitema, Alwin, Dorlo, Thomas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Research
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

Internet

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

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