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What evidence do we need for biomarker qualification?
Leptak, Chris; Menetski, Joseph P; Wagner, John A; Aubrecht, Jiri; Brady, Linda; Brumfield, Martha; Chin, William W; Hoffmann, Steve; Kelloff, Gary; Lavezzari, Gabriela; Ranganathan, Rajesh; Sauer, John-Michael; Sistare, Frank D; Zabka, Tanja; Wholley, David.
Affiliation
  • Leptak C; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
  • Menetski JP; Foundation for the National Institutes of Health (NIH), North Bethesda, MD 20852, USA.
  • Wagner JA; Takeda Pharmaceuticals International Co., Cambridge, MA 02139, USA.
  • Aubrecht J; Pfizer Inc., Groton, CT 06340, USA.
  • Brady L; National Institute of Mental Health, NIH, Bethesda, MD 20892, USA.
  • Brumfield M; Critical Path Institute, Tucson, AZ 85718, USA.
  • Chin WW; Pharmaceutical Research and Manufacturers of America, Washington, DC 20004, USA.
  • Hoffmann S; Foundation for the National Institutes of Health (NIH), North Bethesda, MD 20852, USA.
  • Kelloff G; National Cancer Institute, NIH, Rockville, MD 20850, USA.
  • Lavezzari G; Biocerna LLC, Maple Lawn, MD 20759, USA.
  • Ranganathan R; Massachusetts General Hospital, Boston, MA 02114, USA.
  • Sauer JM; Critical Path Institute, Tucson, AZ 85718, USA.
  • Sistare FD; Merck and Co. Inc., West Point, PA 19486, USA.
  • Zabka T; Genentech Inc., South San Francisco, CA 94080, USA.
  • Wholley D; Foundation for the National Institutes of Health (NIH), North Bethesda, MD 20852, USA. dwholley@fnih.org.
Sci Transl Med ; 9(417)2017 Nov 22.
Article in En | MEDLINE | ID: mdl-29167393
Biomarkers can facilitate all aspects of the drug development process. However, biomarker qualification-the use of a biomarker that is accepted by the U.S. Food and Drug Administration-needs a clear, predictable process. We describe a multistakeholder effort including government, industry, and academia that proposes a framework for defining the amount of evidence needed for biomarker qualification. This framework is intended for broad applications across multiple biomarker categories and uses.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biomarkers Type of study: Prognostic_studies Limits: Animals / Humans Country/Region as subject: America do norte Language: En Journal: Sci Transl Med Journal subject: CIENCIA / MEDICINA Year: 2017 Document type: Article Affiliation country: United States Country of publication: United States
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biomarkers Type of study: Prognostic_studies Limits: Animals / Humans Country/Region as subject: America do norte Language: En Journal: Sci Transl Med Journal subject: CIENCIA / MEDICINA Year: 2017 Document type: Article Affiliation country: United States Country of publication: United States