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Patient Evaluation and OA Study Design: OARSI/Biomarker Qualification


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”.

This article appears in HSS Journal: Volume 8, Number 1.
View the full article at springerlink.com.

About the HSS Journal

HSS Journal, an academic peer-reviewed journal published three times a year, February, July and October. The Journal accepts and publishes peer reviewed articles from around the world that contribute to the advancement of the knowledge of musculoskeletal diseases and disorders.


Virginia Byers Kraus, MD, PhD
Duke University Medical Center, Durham, North Carolina


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