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

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 eligibility...

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Detalles Bibliográficos
Autores principales: Deiteren, Annemie, Coenen, Erwin, Lenders, Sabine, Verwilst, Peter, Mannaert, Erik, Rasschaert, Freya
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8604224/
https://www.ncbi.nlm.nih.gov/pubmed/34378856
http://dx.doi.org/10.1111/cts.13113

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8604224/
https://www.ncbi.nlm.nih.gov/pubmed/34378856
http://dx.doi.org/10.1111/cts.13113

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