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What evidence do we need for biomarker qualification?

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Science Translational Medicine  22 Nov 2017:
Vol. 9, Issue 417, eaal4599
DOI: 10.1126/scitranslmed.aal4599

Article Information

vol. 9 no. 417

PubMed: 
Print ISSN: 
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History: 
  • Received for publication December 16, 2016
  • Accepted for publication November 3, 2017
  • .

Author Information

  1. Chris Leptak1,*,
  2. Joseph P. Menetski2,*,
  3. John A. Wagner3,*,
  4. Jiri Aubrecht4,
  5. Linda Brady5,
  6. Martha Brumfield6,
  7. William W. Chin7,
  8. Steve Hoffmann2,
  9. Gary Kelloff8,
  10. Gabriela Lavezzari9,
  11. Rajesh Ranganathan10,
  12. John-Michael Sauer6,
  13. Frank D. Sistare11,
  14. Tanja Zabka12 and
  15. David Wholley2,
  1. 1Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
  2. 2Foundation for the National Institutes of Health (NIH), North Bethesda, MD 20852, USA.
  3. 3Takeda Pharmaceuticals International Co., Cambridge, MA 02139, USA.
  4. 4Pfizer Inc., Groton, CT 06340, USA.
  5. 5National Institute of Mental Health, NIH, Bethesda, MD 20892, USA.
  6. 6Critical Path Institute, Tucson, AZ 85718, USA.
  7. 7Pharmaceutical Research and Manufacturers of America, Washington, DC 20004, USA.
  8. 8National Cancer Institute, NIH, Rockville, MD 20850, USA.
  9. 9Biocerna LLC, Maple Lawn, MD 20759, USA.
  10. 10Massachusetts General Hospital, Boston, MA 02114, USA.
  11. 11Merck and Co. Inc., West Point, PA 19486, USA.
  12. 12Genentech Inc., South San Francisco, CA 94080, USA.
  1. Corresponding author. Email: dwholley{at}fnih.org
    • * These authors contributed equally to this work.

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