Patient Evaluation and OA Study Design: OARSI/Biomarker Qualification

Colman EG The Food and Drug Administration's Osteoporosis Guidance Document: past, present, and future J Bone Miner Res 200318 1125–810.1359/jbmr.2003.18.6.1125

Conaghan PG Hunter DJ Maillefert JF Reichmann WM Losina E Summary and recommendations of the OARSI FDA osteoarthritis Assessment of Structural Change Working Group Osteoarthritis Cartilage 201119 606–1010.1016/j.joca.2011.02.018

FDA, F. A. D. A. 2010. Guidance for Industry: Qualification Process for Drug Development Tools. October.

Kraus, V. B., Burnett, B., Coindreau, J., Cottrell, S., Eyre, D., Gendreau, M., Gardiner, J., Garnero, P., Hardin, J., Henrotin, Y., Heinegard, D., Ko, A., Lohmander, S., Matthews, G., Menetski, J., Moskowitz, R., Persiani, S., Poole, R., Rousseau, J. C. & Todman, M. 2011. Application of biomarkers in the development of drugs intended for the treatment of osteoarthritis. Osteoarthritis Cartilage.

Wagner JA Williams SA Webster CJ Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs Clin Pharmacol Ther 200781 104–710.1038/sj.clpt.6100017