Towards consensus practices to qualify safety biomarkers for use in early drug development-Reference-Cited by-同舟云学术

Towards consensus practices to qualify safety biomarkers for use in early drug development

Published:2010-05 Issue:5 Volume:28 Page:446-454
ISSN:1087-0156
Container-title:Nature Biotechnology
language:en
Short-container-title:Nat Biotechnol

Author:

Sistare Frank D,Dieterle Frank,Troth Sean,Holder Daniel J,Gerhold David,Andrews-Cleavenger Dina,Baer William,Betton Graham,Bounous Denise,Carl Kevin,Collins Nathaniel,Goering Peter,Goodsaid Federico,Gu Yi-Zhong,Guilpin Valerie,Harpur Ernie,Hassan Alita,Jacobson-Kram David,Kasper Peter,Laurie David,Lima Beatriz Silva,Maciulaitis Romaldas,Mattes William,Maurer Gérard,Obert Leslie Ann,Ozer Josef,Papaluca-Amati Marisa,Phillips Jonathan A,Pinches Mark,Schipper Matthew J,Thompson Karol L,Vamvakas Spiros,Vidal Jean-Marc,Vonderscher Jacky,Walker Elizabeth,Webb Craig,Yu Yan

Publisher

Springer Science and Business Media LLC

Subject

Biomedical Engineering,Molecular Medicine,Applied Microbiology and Biotechnology,Bioengineering,Biotechnology

Link

http://www.nature.com/articles/nbt.1634.pdf

Reference24 articles.

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2. Wagner, J.A. Strategic approach to fit-for-purpose biomarkers in drug development. Annu. Rev. Pharmacol. Toxicol. 48, 631–651 (2008).

3. Wilson, C., Schulz, S. & Waldman, S.A. Biomarker development, commercialization, and regulation: individualization of medicine lost in translation. Clin. Pharmacol. Ther. 81, 153–155 (2007).

4. Sistare, F.D. & DeGeorge, J.J. Preclinical predictors of clinical safety: opportunities for improvement. Clin. Pharmacol. Ther. 82, 210–214 (2007).

5. Food and Drug Administration. Innovation or Stagnation: Challenge And Opportunity on the Critical Path to New Medical Products. http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.pdf (16 March 2004)

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