Clinical qualification; drug development tool; personalized healthcare/medicine
Abstract :
[en] 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 AND RESULTS: 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.
Disciplines :
Rheumatology
Author, co-author :
Henrotin, Yves ; Université de Liège > Département des sciences de la motricité > Unité de recherche sur l'os et le cartilage (U.R.O.C.)
Sanchez, Christelle ; Université de Liège > Département des sciences de la motricité > Unité de recherche sur l'os et le cartilage (U.R.O.C.)
Cornet, Anne
Van de Put, Joachim
Douette, Pierre
Gharbi, Myriam
Language :
English
Title :
Soluble biomarkers development in osteoarthritis: from discovery to personalized medicine.
Publication date :
2015
Journal title :
Biomarkers: Biochemical Indicators of Exposure, Response, and Susceptibility to Chemicals
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