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Biomarker qualification pilot process at the US Food and Drug Administration
New biomarkers of safety and efficacy are becoming powerful tools in drug development. Their application can be accelerated if a consensus can be reached about their qualification for regulatory applications. This consensus requires a review structure within the US Food and Drug Administration (FDA)...
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| Autores principales: | , |
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| Formato: | Artigo |
| Lenguaje: | Inglês |
| Publicado: |
Springer-Verlag
2007
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| Materias: | |
| Acceso en línea: | https://ncbi.nlm.nih.gov/pmc/articles/PMC2751298/ https://ncbi.nlm.nih.gov/pubmed/17408233 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/aapsj0901010 |
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