A Prototypical Process for Creating Evidentiary Standards for Biomarkers and Diagnostics

Clinical Pharmacology and Therapeutics - Tập 83 Số 2 - Trang 368-371 - 2008
C. Anthony Altar1, Dereck D. Amakye2, D Bounos3, Jessica de Bloom4, Glen Clack5, Ralph A. Dean4, Viswanath Devanarayan6, Dong Fu7, Scott R. Furlong5, Lawrence M. Hinman8, Cynthia J. Girman9, CD Lathia10, Lawrence J. Lesko11, Sedigheh Madani12, James Mayne13, Joachim Meyer8, David Raunig12, Philip T. Sager5, S. W. D. Williams14, Peter T.‐H. Wong8, K Zerba15
1Foundation for National Institutes of Health, Washington, DC, USA
2Astra Zeneca, Alderley Park, UK
3Bristol-Myers Squibb, Wallingford, Connecticut, USA
4Lilly Indianapolis Indiana USA
5ASTRA ZENECA, WILMINGTON, DELAWARE, USA
6Abbott, Abbott Park, Illinois, USA
7Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, DC, USA
8Novartis Cambridge Massachusetts USA
9Merck, Rahway, New Jersey, USA
10Bayer Westhaven Connecticut USA
11Food and Drug Administration (FDA), Washington, DC, USA
12Novartis, Rockville, Maryland, USA
13Pfizer New London Connecticut USA
14Decisionability Connecticut USA
15Bristol Myers Squibb, Princeton, New Jersey, USA

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Tài liệu tham khảo

Williams S.A., 2006, Nat. Rev. Drug Discov, 5, 897, 10.1038/nrd2174

Fischoff B., 1978, Policy Sci, 9, 127, 10.1007/BF00143739

Lee J.W, 2006, Pharm. Res, 23, 312, 10.1007/s11095-005-9045-3

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Clinical Pharmacology and Therapeutics

Tập 83 Số 2

368-371

Thông tin tác giả