1.
Nat Rev Drug Discov
; 18(8): 567-568, 2019 07.
Artigo
em Inglês
| MEDLINE
| ID: mdl-31367046
2.
Sci Transl Med
; 9(417)2017 Nov 22.
Artigo
em Inglês
| MEDLINE
| ID: mdl-29167393
RESUMO
Biomarkers can facilitate all aspects of the drug development process. However, biomarker qualification-the use of a biomarker that is accepted by the U.S. Food and Drug Administration-needs a clear, predictable process. We describe a multistakeholder effort including government, industry, and academia that proposes a framework for defining the amount of evidence needed for biomarker qualification. This framework is intended for broad applications across multiple biomarker categories and uses.