Soluble biomarkers development in osteoarthritis: from discovery to personalized medicine.
Biomarkers
; 20(8): 540-6, 2015.
Article
en En
| MEDLINE
| ID: mdl-26954785
ABSTRACT
CONTEXT Specific soluble biomarkers could be a precious tool for diagnosis, prognosis and personalized management of osteoarthritic (OA) patients. OBJECTIVE:
To describe the path of soluble biomarker development from discovery to clinical qualification and regulatory adoption toward OA-related biomarker qualification. METHODS ANDRESULTS:
This review summarizes current guidance on the use of biomarkers in OA in clinical trials and their utility at five stages, including preclinical development and phase 1 to phase 4 trials. It also presents all the available regulatory requirements.CONCLUSIONS:
The path through the adoption of a specific soluble biomarker for OA is steep but is worth the challenge due to the benefit that it can provide.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Osteoartritis
/
Biomarcadores
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Medicina de Precisión
Tipo de estudio:
Diagnostic_studies
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Guideline
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Prognostic_studies
Límite:
Animals
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Humans
Idioma:
En
Año:
2015
Tipo del documento:
Article