ColmanEGThe Food and Drug Administration's Osteoporosis Guidance Document: past, present, and futureJ Bone Miner Res2003181125–810.1359/jbmr.2003.18.6.1125
2.
ConaghanPGHunterDJMaillefertJFReichmannWMLosinaESummary and recommendations of the OARSI FDA osteoarthritis Assessment of Structural Change Working GroupOsteoarthritis Cartilage201119606–1010.1016/j.joca.2011.02.018
3.
FDA, F. A. D. A. 2010. Guidance for Industry: Qualification Process for Drug Development Tools. October.
4.
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.
5.
WagnerJAWilliamsSAWebsterCJBiomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugsClin Pharmacol Ther200781104–710.1038/sj.clpt.6100017