Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization-Reference-Cited by-同舟云学术

Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization

Published:2015-06-06 Issue:1 Volume:98 Page:34-46
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Amur S¹,LaVange L²,Zineh I³,Buckman-Garner S¹,Woodcock J⁴

Affiliation:

1. Office of Translational Sciences, Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring Maryland USA

2. Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring Maryland USA

3. Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring Maryland USA

4. Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/cpt.136/fullpdf

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4. Biomarkers: refining diagnosis and expediting drug development - reality, aspiration and the role of open innovation;Salter;J. Intern. Med,2014

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