Data driven evaluation of healthy volunteer characteristics at screening for phase I clinical trials to inform on study design and optimize screening processes

Abstract Protocols for clinical trials describe inclusion and exclusion criteria based on general and compound‐specific considerations to ensure subject safety and data quality. In phase I clinical trials, healthy volunteers (HVs) are screened against these criteria that often specify predefined eli...

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Autores principales: Annemie Deiteren, Erwin Coenen, Sabine Lenders, Peter Verwilst, Erik Mannaert, Freya Rasschaert
Formato: article
Lenguaje:EN
Publicado: Wiley 2021
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Acceso en línea:https://doaj.org/article/4235eb3060a14b7e8e5f2d52ef5832b6
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