Literature DB >> 16794639

The US Food and Drug Administration perspective on cancer biomarker development.

Steven Gutman1, Larry G Kessler.   

Abstract

Despite the intense interest in biomarker development for cancer management, few biomarker assays for diagnostic uses have been submitted to the US Food and Drug Administration (FDA). What challenges must researchers overcome to bring cancer-detection technologies to the market and, therefore, into clinical use?

Entities:  

Mesh:

Substances:

Year:  2006        PMID: 16794639     DOI: 10.1038/nrc1911

Source DB:  PubMed          Journal:  Nat Rev Cancer        ISSN: 1474-175X            Impact factor:   60.716


  58 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.  Survivin is a potential mediator of prostate cancer metastasis.

Authors:  Min Zhang; John J Coen; Yoshiyuki Suzuki; Michael R Siedow; Andrzej Niemierko; Li-Yan Khor; Alan Pollack; Yifen Zhang; Anthony L Zietman; William U Shipley; Arnab Chakravarti
Journal:  Int J Radiat Oncol Biol Phys       Date:  2010-03-16       Impact factor: 7.038

Review 3.  Envisioning the future of early anticancer drug development.

Authors:  Timothy A Yap; Shahneen K Sandhu; Paul Workman; Johann S de Bono
Journal:  Nat Rev Cancer       Date:  2010-06-10       Impact factor: 60.716

Review 4.  Biomarkers for Alzheimer's disease: academic, industry and regulatory perspectives.

Authors:  Harald Hampel; Richard Frank; Karl Broich; Stefan J Teipel; Russell G Katz; John Hardy; Karl Herholz; Arun L W Bokde; Frank Jessen; Yvonne C Hoessler; Wendy R Sanhai; Henrik Zetterberg; Janet Woodcock; Kaj Blennow
Journal:  Nat Rev Drug Discov       Date:  2010-07       Impact factor: 84.694

5.  Isolation of microarray-grade total RNA, microRNA, and DNA from a single PAXgene blood RNA tube.

Authors:  Mogens Kruhøffer; Lars Dyrskjøt; Thorsten Voss; Raija L P Lindberg; Ralf Wyrich; Thomas Thykjaer; Torben F Orntoft
Journal:  J Mol Diagn       Date:  2007-08-09       Impact factor: 5.568

6.  [Molecular pathology as an necessity: its role in diagnostic and predictive pathology].

Authors:  K W Schmid
Journal:  Pathologe       Date:  2009-03       Impact factor: 1.011

7.  Accurate inclusion mass screening: a bridge from unbiased discovery to targeted assay development for biomarker verification.

Authors:  Jacob D Jaffe; Hasmik Keshishian; Betty Chang; Theresa A Addona; Michael A Gillette; Steven A Carr
Journal:  Mol Cell Proteomics       Date:  2008-06-04       Impact factor: 5.911

8.  Protein quantitation through targeted mass spectrometry: the way out of biomarker purgatory?

Authors:  Steven A Carr; Leigh Anderson
Journal:  Clin Chem       Date:  2008-11       Impact factor: 8.327

9.  [Molecular pathological identification of predictive biomarkers: a new task for diagnostic pathology].

Authors:  K W Schmid
Journal:  Urologe A       Date:  2008-10       Impact factor: 0.639

10.  An analysis of a multiple biomarker panel to better predict prostate cancer metastasis after radical prostatectomy.

Authors:  Alison Y Zhang; Karen Chiam; Ygal Haupt; Stephen Fox; Simone Birch; Wayne Tilley; Lisa M Butler; Karen Knudsen; Clay Comstock; Krishan Rasiah; Judith Grogan; Kate L Mahon; Tina Bianco-Miotto; Carmela Ricciardelli; Maret Böhm; Susan Henshall; Warick Delprado; Phillip Stricker; Lisa G Horvath; James G Kench
Journal:  Int J Cancer       Date:  2018-12-04       Impact factor: 7.396

View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.