Literature DB >> 18280028

Strategic paths for biomarker qualification.

Federico M Goodsaid1, Felix W Frueh, William Mattes.   

Abstract

Biomarkers may be qualified using different qualification processes. A passive approach for qualification has been to accept the end of discussions in the scientific literature as an indication that a biomarker has been accepted. An active approach to qualification requires development of a comprehensive process by which a consensus may be reached about the qualification of a biomarker. Active strategies for qualification include those associated with context-independent as well as context-dependent qualifications.

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Year:  2008        PMID： 18280028     DOI： 10.1016/j.tox.2007.12.023

Source DB:  PubMed          Journal:  Toxicology        ISSN： 0300-483X            Impact factor:   4.221


  27 in total

1.  Research at the interface of industry, academia and regulatory science.

Authors:  William B Mattes; Elizabeth Gribble Walker; Eric Abadie; Frank D Sistare; Jacky Vonderscher; Janet Woodcock; Raymond L Woosley
Journal:  Nat Biotechnol       Date:  2010-05       Impact factor: 54.908

2.  Evolution of biomarker qualification at the health authorities.

Authors:  Federico Goodsaid; Marisa Papaluca
Journal:  Nat Biotechnol       Date:  2010-05       Impact factor: 54.908

Review 3.  Integrating ADNI results into Alzheimer's disease drug development programs.

Authors:  Jeffrey L Cummings
Journal:  Neurobiol Aging       Date:  2010-05-05       Impact factor: 4.673

Review 4.  Biomarkers and surrogate end points--the challenge of statistical validation.

Authors:  Marc Buyse; Daniel J Sargent; Axel Grothey; Alastair Matheson; Aimery de Gramont
Journal:  Nat Rev Clin Oncol       Date:  2010-04-06       Impact factor: 66.675

5.  Quantitative imaging test approval and biomarker qualification: interrelated but distinct activities.

Authors:  Andrew J Buckler; Linda Bresolin; N Reed Dunnick; Daniel C Sullivan; Hugo J W L Aerts; Bernard Bendriem; Claus Bendtsen; Ronald Boellaard; John M Boone; Patricia E Cole; James J Conklin; Gary S Dorfman; Pamela S Douglas; Willy Eidsaunet; Cathy Elsinger; Richard A Frank; Constantine Gatsonis; Maryellen L Giger; Sandeep N Gupta; David Gustafson; Otto S Hoekstra; Edward F Jackson; Lisa Karam; Gary J Kelloff; Paul E Kinahan; Geoffrey McLennan; Colin G Miller; P David Mozley; Keith E Muller; Rick Patt; David Raunig; Mark Rosen; Haren Rupani; Lawrence H Schwartz; Barry A Siegel; A Gregory Sorensen; Richard L Wahl; John C Waterton; Walter Wolf; Gudrun Zahlmann; Brian Zimmerman
Journal:  Radiology       Date:  2011-02-15       Impact factor: 11.105

6.  An accelerated pathway for targeted cancer therapies.

Authors:  Mark McClellan; Joshua Benner; Richard Schilsky; David Epstein; Ray Woosley; Stephen Friend; David Sidransky; Cindy Geoghegan; David Kessler
Journal:  Nat Rev Drug Discov       Date:  2011-02       Impact factor: 84.694

7.  A Roadmap for the Development of Applied Computational Psychiatry.

Authors:  Martin P Paulus; Quentin J M Huys; Tiago V Maia
Journal:  Biol Psychiatry Cogn Neurosci Neuroimaging       Date:  2016-09

Review 8.  Blood cytokines as biomarkers of in vivo toxicity in preclinical safety assessment: considerations for their use.

Authors:  Jacqueline M Tarrant
Journal:  Toxicol Sci       Date:  2010-05-06       Impact factor: 4.849

Review 9.  Proteomics and metabolomics in renal transplantation-quo vadis?

Authors:  Rahul Bohra; Jacek Klepacki; Jelena Klawitter; Jost Klawitter; Joshua M Thurman; Uwe Christians
Journal:  Transpl Int       Date:  2012-11-21       Impact factor: 3.782

Review 10.  From differentiating metabolites to biomarkers.

Authors:  Albert Koulman; Geoffrey A Lane; Scott J Harrison; Dietrich A Volmer
Journal:  Anal Bioanal Chem       Date:  2009-03-11       Impact factor: 4.142
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