Perspectives on statistical strategies for the regulatory biomarker qualification process

Qualification of a biomarker for use in a medical product development program requires a statistical strategy that aligns available evidence with the proposed context of use (COU), identifies any data gaps to be filled and plans any additional research required to support the qualification. Accumula...

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Detalles Bibliográficos
Autores principales: Hendrix, Suzanne B, Mogg, Robin, Wang, Sue Jane, Chakravarty, Aloka, Romero, Klaus, Dickson, Samuel P, Sauer, John-Michael, McShane, Lisa M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Future Medicine Ltd 2021
Materias:
Perspective
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8293027/
https://www.ncbi.nlm.nih.gov/pubmed/34037457
http://dx.doi.org/10.2217/bmm-2020-0523

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8293027/
https://www.ncbi.nlm.nih.gov/pubmed/34037457
http://dx.doi.org/10.2217/bmm-2020-0523

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