Patient Evaluation and OA Study Design: OARSI/Biomarker Qualification
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Qualification is defined as the “graded, ‘fit-for-purpose’ evidentiary process linking a biomarker with biology and clinical endpoints” . As recently defined by the Federal Drug Administration (FDA), “qualification is a conclusion that within the stated context (manner and purpose) of use, the results of assessment with a drug development tool (DDT) can be relied upon to have a specific interpretation and application in drug development and regulatory decision making” .
Biomarkers of OA
Keywordbiomarkers osteoarthritis FDA qualification drug development tools
The author wishes to acknowledge NIH NIAMS PO1 AR050245, NIA Claude D. Pepper Older Americans Independence Centers 5P30 AG028716, and NIA R21 AG039782-01 for funding support.
The author certifies that he or she has no commercial associations (e.g., consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article.
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