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Retricted access

Research article

First published 2018-2

Preclinical biomarker qualification

John-Michael Sauer, Amy C Porter, for the Biomarker Programs,Predictive Safety Testing Consortium

Experimental Biology and Medicine

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Review article

First published 2021-11

Qualification of translational safety biomarkers

John-Michael Sauer, Amy C Porter

Experimental Biology and Medicine

Free access

Review article

First published 2011-12

Recommendations for the Evaluation of Pathology Data in Nonclinical Safety Biomarker Qualification Studies

John E. Burkhardt, Karamjeet Pandher, Phillip F. Solter [...]

Toxicologic Pathology

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Research article

First published 2018-2

Regulatory landscapes for biomarkers and diagnostic tests: Qualification,approval,and role in clinical practice

William B. Mattes, Federico Goodsaid

Experimental Biology and Medicine

Open access

Review article

First published 2016-11-1

Cerebrospinal Fluid Biomarkers for Alzheimer’s Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team

Stephen P. Arnerić, Richard Batrla-Utermann, Laurel Beckett [...]

Journal of Alzheimer’s Disease

Free access

Research article

First published 2015-1

Recent Successes in the Identification,Development,and Qualification of Translational Biomarkers

Daniela Ennulat, Scott Adler

Toxicologic Pathology

Retricted access

Meeting report

First published 2012-2

Patient Evaluation and OA Study Design: OARSI/Biomarker Qualification

Virginia Byers Kraus

HSS Journal®: The Musculoskeletal Journal of Hospital for Special Surgery

Free access

Research article

First published 2014-1

Safety Biomarkers in Preclinical Development

V. G. Sasseville, K. G. Mansfield, D. J. Brees

Veterinary Pathology

Free access

Research article

First published 2017-10

Skeletal Muscle Injury Biomarkers: Assay Qualification Efforts and Translation to the Clinic

Richard A. Goldstein

Toxicologic Pathology

Free access

Research article

First published 2015-8

Regulatory Forum Opinion Piece*

Rodney Rouse

Toxicologic Pathology

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