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A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
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HSS Journal ®
Published in: HSS Journal ® 1/2012

01-02-2012 | HSS Osteoarthritis Symposium: Frontiers in OA

Patient Evaluation and OA Study Design: OARSI/Biomarker Qualification

Author: Virginia Byers Kraus, MD, PhD

Published in: HSS Journal ® | Issue 1/2012

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Excerpt

Qualification is defined as the “graded, ‘fit-for-purpose’ evidentiary process linking a biomarker with biology and clinical endpoints” [5]. 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” [3]. …
Literature
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Colman, E. G. 2003. The Food and Drug Administration's Osteoporosis Guidance Document: past, present, and future. J Bone Miner Res, 18, 1125–8.PubMedCrossRef
2.
Conaghan, P. G., Hunter, D. J., Maillefert, J. F., Reichmann, W. M. & Losina, E. 2011. Summary and recommendations of the OARSI FDA osteoarthritis Assessment of Structural Change Working Group. Osteoarthritis Cartilage, 19, 606–10.PubMedCrossRef
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.
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Wagner, J. A., Williams, S. A. & Webster, C. J. 2007. Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs. Clin Pharmacol Ther, 81, 104–7.PubMedCrossRef
Metadata
Title
Patient Evaluation and OA Study Design: OARSI/Biomarker Qualification
Author
Virginia Byers Kraus, MD, PhD
Publication date
01-02-2012
Publisher
Springer-Verlag
Published in
HSS Journal ® / Issue 1/2012
Print ISSN: 1556-3316
Electronic ISSN: 1556-3324
DOI
https://doi.org/10.1007/s11420-011-9234-z

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