Literature DB >> 16886901

Process map proposal for the validation of genomic biomarkers.

Federico Goodsaid1, Felix Frueh.   

Abstract

How can we encourage the application of novel genomic biomarkers in drug development? A major step in this direction would be a consensus on how to interpret results from measurements of these biomarkers in regulatory submissions. A transparent process for genomic biomarker validation would be of value both for the pharmaceutical industry as well as for regulatory agencies associated with it. A discussion on process map proposals for genomic biomarker validation can help with drafting of guidance documents for this process.

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Year:  2006        PMID： 16886901     DOI： 10.2217/14622416.7.5.773

Source DB:  PubMed          Journal:  Pharmacogenomics        ISSN： 1462-2416            Impact factor:   2.533


  15 in total

1.  Biomarker qualification pilot process at the US Food and Drug Administration.

Authors:  Federico Goodsaid; Felix Frueh
Journal:  AAPS J       Date:  2007-03-23       Impact factor: 4.009

2.  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

Review 3.  Regulatory landscapes for biomarkers and diagnostic tests: Qualification, approval, and role in clinical practice.

Authors:  William B Mattes; Federico Goodsaid
Journal:  Exp Biol Med (Maywood)       Date:  2017-11-07

4.  [Serum-based biomarkers for psychiatric disorders].

Authors:  S Bahn; E Schwarz
Journal:  Nervenarzt       Date:  2011-11       Impact factor: 1.214

Review 5.  A pathway and approach to biomarker validation and qualification for osteoarthritis clinical trials.

Authors:  David J Hunter; Elena Losina; Ali Guermazi; Deb Burstein; Marissa N Lassere; Virginia Kraus
Journal:  Curr Drug Targets       Date:  2010-05       Impact factor: 3.465

Review 6.  Validation of analytic methods for biomarkers used in drug development.

Authors:  Cindy H Chau; Olivier Rixe; Howard McLeod; William D Figg
Journal:  Clin Cancer Res       Date:  2008-10-01       Impact factor: 12.531

7.  Inclusion of biomarkers for detecting perturbations in the heart and lung and lipid/carbohydrate metabolism in National Toxicology Program studies.

Authors:  June K Dunnick; Kristina A Thayer; Gregory S Travlos
Journal:  Toxicol Sci       Date:  2007-05-08       Impact factor: 4.849

Review 8.  The current status of biomarkers for predicting toxicity.

Authors:  Sarah Campion; Jiri Aubrecht; Kim Boekelheide; David W Brewster; Vishal S Vaidya; Linnea Anderson; Deborah Burt; Edward Dere; Kathleen Hwang; Sara Pacheco; Janani Saikumar; Shelli Schomaker; Mark Sigman; Federico Goodsaid
Journal:  Expert Opin Drug Metab Toxicol       Date:  2013-08-21       Impact factor: 4.481

9.  Mass Spectrometry-Based Multiplexing for the Analysis of Biomarkers in Drug Development and Clinical Diagnostics- How Much is too Much?

Authors:  Uwe Christians; Jacek Klepacki; Touraj Shokati; Jost Klawitter; Jelena Klawitter
Journal:  Microchem J       Date:  2012-11-01       Impact factor: 4.821

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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