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Journal of Biopharmaceutical Statistics Volume 14, 2004 - Issue 3
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Original Articles

Some Statistical and Regulatory Issues in the Evaluation of Genetic and Genomic Tests

Gregory Campbell Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, Maryland, USA; Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 1350 Piccard Drive, HFZ-542, Rockville, MD, 20850, USACorrespondence[email protected]
Pages 539-552 | Received 01 Jul 2003, Accepted 01 Dec 2003, Published online: 02 Feb 2007

Citations (16)

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Read on this site (4)

Gregory Campbell & Lilly Q. Yue. (2016) Statistical innovations in the medical device world sparked by the FDA. Journal of Biopharmaceutical Statistics 26:1, pages 3-16.
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Bertrand R Jordan. (2010) Is there a niche for DNA microarrays in molecular diagnostics?. Expert Review of Molecular Diagnostics 10:7, pages 875-882.
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Samir Lababidi. (2007) Challenges in DNA Microarray Studies from the Regulatory Perspective. Journal of Biopharmaceutical Statistics 18:1, pages 183-202.
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Gregory Campbell*. (2007) Statistics in the World of Medical Devices: The Contrast with Pharmaceuticals. Journal of Biopharmaceutical Statistics 18:1, pages 4-19.
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Articles from other publishers (12)

Gregory Campbell, Heng Li, Gene Pennello & Lilly Q. Yue. 2014. Wiley StatsRef: Statistics Reference Online. Wiley StatsRef: Statistics Reference Online 1 32 .
Bertrand R. Jordan. 2014. Transcriptomics in Health and Disease. Transcriptomics in Health and Disease 327 340 .
Donna M. Wolk. 2013. Clinical Laboratory Management. Clinical Laboratory Management 832 848 .
Maria P. Pavlou, Ivan M. Blasutig & Eleftherios P. Diamandis. 2013. Comprehensive Biomarker Discovery and Validation for Clinical Application. Comprehensive Biomarker Discovery and Validation for Clinical Application 334 352 .
Greg Campbell, Lilly Yue, Gene Pennello & Mary Barrick. 2012. Encyclopedia of Biopharmaceutical Statistics, Third Edition. Encyclopedia of Biopharmaceutical Statistics, Third Edition 756 767 .
Bertrand Jordan. 2012. Microarrays in Diagnostics and Biomarker Development. Microarrays in Diagnostics and Biomarker Development 21 27 .
Shein-Chung ChowGreg Campbell, Lilly Q. Yue, Gene Pennello & Mary K. Barrick. 2010. Encyclopedia of Biopharmaceutical Statistics. Encyclopedia of Biopharmaceutical Statistics 756 767 .
Russell A. Wilke, Debbie W. Lin, Dan M. Roden, Paul B. Watkins, David Flockhart, Issam Zineh, Kathleen M. Giacomini & Ronald M. Krauss. (2007) Identifying genetic risk factors for serious adverse drug reactions: current progress and challenges. Nature Reviews Drug Discovery 6:11, pages 904-916.
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Todd G. Nick & Kathleen M. Campbell. 2007. Topics in Biostatistics. Topics in Biostatistics 273 301 .
Federico InnocentiMark J Ratain. (2006) Pharmacogenetics of irinotecan: clinical perspectives on the utility of genotyping. Pharmacogenomics 7:8, pages 1211-1221.
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Steven Gutman & Larry G. Kessler. (2006) The US Food and Drug Administration perspective on cancer biomarker development. Nature Reviews Cancer 6:7, pages 565-571.
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Ansar Jawaid, Rachael Moore, Ruth March & Bryan J. Barratt. (2006) Gene mapping strategies for complex disease and drug response. Drug Discovery Today: Technologies 3:2, pages 131-136.
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