Promoting Adoption of the 3Rs through Regulatory Qualification

Author:

Walker Elizabeth Gribble,Baker Amanda F.,Sauer John-Michael

Publisher

Oxford University Press (OUP)

Subject

General Biochemistry, Genetics and Molecular Biology,Animal Science and Zoology,General Medicine

Reference13 articles.

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

2. Building a roadmap to biomarker qualification: Challenges and opportunities;Amur;Biomark Med,2015

3. Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium

4. EMA's Letter of Support . 2016. Available online (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000319.jsp#section15), accessed on October 12, 2016.

5. FDA's Critical Path Opportunities List . 2006. Available online (http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/UCM077258.pdf), accessed on October 12, 2016.

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