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Retricted access

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

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Other

First published 1999-4

Qualified Statisticians in the European Pharmaceutical Industry: Report of a European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) Working Group

David Morgan

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 2012-4

Experiences of non-UK-qualified doctors working within the UK regulatory framework: a qualitative study

A Slowther, GA Lewando Hundt, J Purkis [...]

Journal of the Royal Society of Medicine

Retricted access

Research article

First published 1992-4

Qualifications of Investigators for Clinical Investigations Conducted under an Ind: A Discussion Paper

David M. Cocchetto, Jon R. Wallace

Therapeutic Innovation & Regulatory Science

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

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

Open access

Review article

First published 2020

Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape

Mariya Gromova, Annegret Vaggelas, Gabriele Dallmann [...]

Biomarker Insights

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Research article

First published 2014-3

Evolving Global Regulatory Science Through the Voluntary Submission of Data

Elizabeth Gribble Walker, Martha Brumfield, Carolyn Compton [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2013-11

Coalition Against Major Diseases

Diane Stephenson, Enrique Aviles, Lisa J. Bain [...]

Therapeutic Innovation & Regulatory Science

Open access

Article commentary

First published 2022-03-01

Stride Velocity 95th Centile: Insights into Gaining Regulatory Qualification of the First Wearable-Derived Digital Endpoint for use in Duchenne Muscular Dystrophy Trials

Laurent Servais, Karl Yen, Maitea Guridi [...]

Journal of Neuromuscular Diseases

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