Journal
BIOMARKERS
Volume 20, Issue 8, Pages 540-546Publisher
TAYLOR & FRANCIS LTD
DOI: 10.3109/1354750X.2015.1123363
Keywords
personalized healthcare/medicine; drug development tool; Clinical qualification
Categories
Funding
- Nestle
- Tilman SA
- LABHRA
- BioIberica
- Royal Canin
- Expanscience
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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.
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