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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...
| Autores principales: | , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Future Medicine Ltd
2021
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| Materias: | |
| 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 |