Karol L Thompson

Division of Drug Safety Research, Office of Testing and Research, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

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October 2013

Comparison of urinary and serum levels of di-22:6-bis(monoacylglycerol)phosphate as noninvasive biomarkers of phospholipidosis in rats.

Authors:

Karol L Thompson Jun Zhang Sharron Stewart Barry A Rosenzweig Katherine Shea Daniel Mans Thomas Colatsky

Toxicol Lett 2012 Sep 22;213(2):285-91. Epub 2012 Jul 22.

Division of Drug Safety Research, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA.

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September 2012

Comparison of the diagnostic accuracy of di-22:6-bis(monoacylglycerol)phosphate and other urinary phospholipids for drug-induced phospholipidosis or tissue injury in the rat.

Authors:

Karol L Thompson Kylie Haskins Barry A Rosenzweig Sharron Stewart Jun Zhang David Peters Alan Knapton Rodney Rouse Daniel Mans Thomas Colatsky

Int J Toxicol 2012 Jan-Feb;31(1):14-24. Epub 2012 Jan 19.

Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Building 64, Room 2036, Silver Spring, MD 20993, USA.

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June 2012

An adaptable method using human mixed tissue ratiometric controls for benchmarking performance on gene expression microarrays in clinical laboratories.

Authors:

P Scott Pine Barry A Rosenzweig Karol L Thompson

BMC Biotechnol 2011 Apr 12;11:38. Epub 2011 Apr 12.

Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993 USA.

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April 2011

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

Nat Biotechnol 2010 May 10;28(5):455-62. Epub 2010 May 10.

Novartis Pharma AG, Basel, Switzerland.

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May 2010

Towards consensus practices to qualify safety biomarkers for use in early drug development.

Nat Biotechnol 2010 May 10;28(5):446-54. Epub 2010 May 10.

Merck Research Laboratories, Safety Assessment, West Point, Pennsylvania, USA.

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May 2010

Early alterations in heart gene expression profiles associated with doxorubicin cardiotoxicity in rats.

Authors:

Karol L Thompson Barry A Rosenzweig Jun Zhang Alan D Knapton Ronald Honchel Steven E Lipshultz Jacques Retief Frank D Sistare Eugene H Herman

Cancer Chemother Pharmacol 2010 Jul 14;66(2):303-14. Epub 2009 Nov 14.

Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.

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July 2010

Comparison of the diagnostic performance of human whole genome microarrays using mixed-tissue RNA reference samples.

Authors:

Karol L Thompson P Scott Pine

Toxicol Lett 2009 Apr 7;186(1):58-61. Epub 2008 Sep 7.

Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

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April 2009

Sources of variation in baseline gene expression levels from toxicogenomics study control animals across multiple laboratories.

Authors:

Michael J Boedigheimer Russell D Wolfinger Michael B Bass Pierre R Bushel Jeff W Chou Matthew Cooper J Christopher Corton Jennifer Fostel Susan Hester Janice S Lee Fenglong Liu Jie Liu Hui-Rong Qian John Quackenbush Syril Pettit Karol L Thompson

BMC Genomics 2008 Jun 12;9:285. Epub 2008 Jun 12.

CDER, US FDA, Silver Spring, MD 20993, USA .

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June 2008

Quality control of microarray assays for toxicogenomic and in vitro diagnostic applications.

Authors:

Karol L Thompson Joseph Hackett

Methods Mol Biol 2008 ;460:45-68

Division of Applied Pharmacology Research, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

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August 2008

Comparison of kidney injury molecule-1 and other nephrotoxicity biomarkers in urine and kidney following acute exposure to gentamicin, mercury, and chromium.

Authors:

Yuzhao Zhou Vishal S Vaidya Ronald P Brown Jun Zhang Barry A Rosenzweig Karol L Thompson Terry J Miller Joseph V Bonventre Peter L Goering

Toxicol Sci 2008 Jan 13;101(1):159-70. Epub 2007 Oct 13.

Center for Devices and Radiological Health, U.S. Food and Drug Administration, White Oak Life Sciences Laboratory, Silver Spring, MD 20993, USA.

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January 2008

Characterization of the effect of sample quality on high density oligonucleotide microarray data using progressively degraded rat liver RNA.

Authors:

Karol L Thompson P Scott Pine Barry A Rosenzweig Yaron Turpaz Jacques Retief

BMC Biotechnol 2007 Sep 13;7:57. Epub 2007 Sep 13.

Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

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September 2007

The utility of a rodent model in detecting pediatric drug-induced nephrotoxicity.

Authors:

Parvaneh Espandiari Jun Zhang Barry A Rosenzweig Vishal S Vaidya Jinchun Sun Laura Schnackenberg Eugene H Herman Alan Knapton Joseph V Bonventre Richard D Beger Karol L Thompson Joseph Hanig

Toxicol Sci 2007 Oct 17;99(2):637-48. Epub 2007 Jul 17.

Center for Drug Evaluation and Research, Silver Spring, Maryland 20993, USA.

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October 2007

Improvement in the reproducibility and accuracy of DNA microarray quantification by optimizing hybridization conditions.

Authors:

Tao Han Cathy D Melvin Leming Shi William S Branham Carrie L Moland P Scott Pine Karol L Thompson James C Fuscoe

BMC Bioinformatics 2006 Sep 6;7 Suppl 2:S17. Epub 2006 Sep 6.

Center for Functional Genomics, National Center for Toxicological Research, US FDA, Jefferson, AR 72079, USA.

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September 2006

The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements.

Authors:

Leming Shi Laura H Reid Wendell D Jones Richard Shippy Janet A Warrington Shawn C Baker Patrick J Collins Francoise de Longueville Ernest S Kawasaki Kathleen Y Lee Yuling Luo Yongming Andrew Sun James C Willey Robert A Setterquist Gavin M Fischer Weida Tong Yvonne P Dragan David J Dix Felix W Frueh Frederico M Goodsaid Damir Herman Roderick V Jensen Charles D Johnson Edward K Lobenhofer Raj K Puri Uwe Schrf Jean Thierry-Mieg Charles Wang Mike Wilson Paul K Wolber Lu Zhang Shashi Amur Wenjun Bao Catalin C Barbacioru Anne Bergstrom Lucas Vincent Bertholet Cecilie Boysen Bud Bromley Donna Brown Alan Brunner Roger Canales Xiaoxi Megan Cao Thomas A Cebula James J Chen Jing Cheng Tzu-Ming Chu Eugene Chudin John Corson J Christopher Corton Lisa J Croner Christopher Davies Timothy S Davison Glenda Delenstarr Xutao Deng David Dorris Aron C Eklund Xiao-hui Fan Hong Fang Stephanie Fulmer-Smentek James C Fuscoe Kathryn Gallagher Weigong Ge Lei Guo Xu Guo Janet Hager Paul K Haje Jing Han Tao Han Heather C Harbottle Stephen C Harris Eli Hatchwell Craig A Hauser Susan Hester Huixiao Hong Patrick Hurban Scott A Jackson Hanlee Ji Charles R Knight Winston P Kuo J Eugene LeClerc Shawn Levy Quan-Zhen Li Chunmei Liu Ying Liu Michael J Lombardi Yunqing Ma Scott R Magnuson Botoul Maqsodi Tim McDaniel Nan Mei Ola Myklebost Baitang Ning Natalia Novoradovskaya Michael S Orr Terry W Osborn Adam Papallo Tucker A Patterson Roger G Perkins Elizabeth H Peters Ron Peterson Kenneth L Philips P Scott Pine Lajos Pusztai Feng Qian Hongzu Ren Mitch Rosen Barry A Rosenzweig Raymond R Samaha Mark Schena Gary P Schroth Svetlana Shchegrova Dave D Smith Frank Staedtler Zhenqiang Su Hongmei Sun Zoltan Szallasi Zivana Tezak Danielle Thierry-Mieg Karol L Thompson Irina Tikhonova Yaron Turpaz Beena Vallanat Christophe Van Stephen J Walker Sue Jane Wang Yonghong Wang Russ Wolfinger Alex Wong Jie Wu Chunlin Xiao Qian Xie Jun Xu Wen Yang Liang Zhang Sheng Zhong Yaping Zong William Slikker

Nat Biotechnol 2006 Sep;24(9):1151-61

National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas 72079, USA.

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September 2006

Use of a mixed tissue RNA design for performance assessments on multiple microarray formats.

Nucleic Acids Res 2005 Dec 23;33(22):e187. Epub 2005 Dec 23.

Center for Drug Evaluation and Research, US FDA, Silver Spring, MD 20993, USA.

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December 2005

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