Literature DB >> 20458312

Evolution of biomarker qualification at the health authorities.

Federico Goodsaid1, Marisa Papaluca.   

Abstract

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Year:  2010        PMID: 20458312     DOI: 10.1038/nbt0510-441

Source DB:  PubMed          Journal:  Nat Biotechnol        ISSN: 1087-0156            Impact factor:   54.908


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  5 in total

1.  A prototypical process for creating evidentiary standards for biomarkers and diagnostics.

Authors:  C A Altar; D Amakye; D Bounos; J Bloom; G Clack; R Dean; V Devanarayan; D Fu; S Furlong; L Hinman; C Girman; C Lathia; L Lesko; S Madani; J Mayne; J Meyer; D Raunig; P Sager; S A Williams; P Wong; K Zerba
Journal:  Clin Pharmacol Ther       Date:  2007-12-19       Impact factor: 6.875

Review 2.  [Tasks and expectations for drug design based on pharmacogenomics].

Authors:  Yoshiaki Uyama
Journal:  Nihon Yakurigaku Zasshi       Date:  2005-12

Review 3.  Strategic paths for biomarker qualification.

Authors:  Federico M Goodsaid; Felix W Frueh; William Mattes
Journal:  Toxicology       Date:  2008-01-06       Impact factor: 4.221

Review 4.  The value, qualification, and regulatory use of surrogate end points in drug development.

Authors:  C D Lathia; D Amakye; W Dai; C Girman; S Madani; J Mayne; P MacCarthy; P Pertel; L Seman; A Stoch; P Tarantino; C Webster; S Williams; J A Wagner
Journal:  Clin Pharmacol Ther       Date:  2009-05-27       Impact factor: 6.875

5.  The Innovative Medicines Initiative: a pre-competitive initiative to enhance the biomedical science base of Europe to expedite the development of new medicines for patients.

Authors:  A Jackie Hunter
Journal:  Drug Discov Today       Date:  2008-04-24       Impact factor: 7.851

  5 in total
  9 in total

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

Authors:  Frank Dieterle; Frank Sistare; Federico Goodsaid; Marisa Papaluca; Josef S Ozer; Craig P Webb; William Baer; Anthony Senagore; Matthew J Schipper; Jacky Vonderscher; Stefan Sultana; David L Gerhold; Jonathan A Phillips; Gérard Maurer; Kevin Carl; David Laurie; Ernie Harpur; Manisha Sonee; Daniela Ennulat; Dan Holder; Dina Andrews-Cleavenger; Yi-Zhong Gu; Karol L Thompson; Peter L Goering; Jean-Marc Vidal; Eric Abadie; Romaldas Maciulaitis; David Jacobson-Kram; Albert F Defelice; Elizabeth A Hausner; Melanie Blank; Aliza Thompson; Patricia Harlow; Douglas Throckmorton; Shen Xiao; Nancy Xu; William Taylor; Spiros Vamvakas; Bruno Flamion; Beatriz Silva Lima; Peter Kasper; Markku Pasanen; Krishna Prasad; Sean Troth; Denise Bounous; Denise Robinson-Gravatt; Graham Betton; Myrtle A Davis; Jackie Akunda; James Eric McDuffie; Laura Suter; Leslie Obert; Magalie Guffroy; Mark Pinches; Supriya Jayadev; Eric A Blomme; Sven A Beushausen; Valérie G Barlow; Nathaniel Collins; Jeff Waring; David Honor; Sandra Snook; Jinhe Lee; Phil Rossi; Elizabeth Walker; William Mattes
Journal:  Nat Biotechnol       Date:  2010-05-10       Impact factor: 54.908

Review 2.  Pharmacogenetics in the evaluation of new drugs: a multiregional regulatory perspective.

Authors:  Marc Maliepaard; Charity Nofziger; Marisa Papaluca; Issam Zineh; Yoshiaki Uyama; Krishna Prasad; Christian Grimstein; Michael Pacanowski; Falk Ehmann; Silvia Dossena; Markus Paulmichl
Journal:  Nat Rev Drug Discov       Date:  2013-02       Impact factor: 84.694

Review 3.  Early markers of obesity-related renal injury in childhood.

Authors:  Wei Ding; Robert H Mak
Journal:  Pediatr Nephrol       Date:  2014-10-17       Impact factor: 3.714

Review 4.  Development of blood biomarkers for drug-induced liver injury: an evaluation of their potential for risk assessment and diagnostics.

Authors:  David E Amacher; Shelli J Schomaker; Jiri Aubrecht
Journal:  Mol Diagn Ther       Date:  2013-12       Impact factor: 4.074

5.  Evaluating the Use of KIM-1 in Drug Development and Research Following FDA Qualification.

Authors:  Ru Chen; Sarmistha Sanyal; Aliza Thompson; Joachim H Ix; Kylie Haskins; Laurie Muldowney; Shashi Amur
Journal:  Clin Pharmacol Ther       Date:  2018-05-15       Impact factor: 6.875

6.  Current challenges in translational pain research.

Authors:  Jianren Mao
Journal:  Trends Pharmacol Sci       Date:  2012-09-06       Impact factor: 14.819

Review 7.  Predictive biomarkers: a paradigm shift towards personalized cancer medicine.

Authors:  Nicholas B La Thangue; David J Kerr
Journal:  Nat Rev Clin Oncol       Date:  2011-08-23       Impact factor: 66.675

Review 8.  Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape.

Authors:  Mariya Gromova; Annegret Vaggelas; Gabriele Dallmann; Diane Seimetz
Journal:  Biomark Insights       Date:  2020-12-08

9.  Biomarkers in Medicines Development-From Discovery to Regulatory Qualification and Beyond.

Authors:  Natalie M Hendrikse; Jordi Llinares Garcia; Thorsten Vetter; Anthony J Humphreys; Falk Ehmann
Journal:  Front Med (Lausanne)       Date:  2022-04-26
  9 in total

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