Translational Medicine and the Value of Biomarker Qualification-Reference-Cited by-同舟云学术

Translational Medicine and the Value of Biomarker Qualification

Published:2010-09 Issue:47 Volume:2 Page:
ISSN:1946-6234
Container-title:Science Translational Medicine
language:en
Short-container-title:Sci. Transl. Med.

Author:

Goodsaid Federico M.¹,Mendrick Donna L.²

Affiliation:

1. Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Silver Spring, MD 20903, USA.

2. Division of Systems Biology, National Center for Toxicological Research, FDA, Jefferson, AR 72079, USA.

Abstract

The U.S. Food and Drug Administration's new process for biomarker qualification developed from a need for better biomarkers of renal injury.

Publisher

American Association for the Advancement of Science (AAAS)

Subject

General Medicine

Reference20 articles.

1. Mechanistic biomarkers for cytotoxic acute kidney injury

2. FDA Critical Path Opportunities List www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/UCM077258.pdf. (2006).

3. Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact

4. Strategic paths for biomarker qualification

5. FDA Draft Guidance for Industry Qualification Process for Drug Development Tools (2010).

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