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Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact.
Published in:
2010
By:
- Goodsaid, Federico M.;
- Amur, Shashi;
- Aubrecht, Jiri;
- Burczynski, Michael E.;
- Carl, Kevin;
- Catalano, Jennifer;
- Charlab, Rosane;
- Close, Sandra;
- Cornu-Artis, Catherine;
- Essioux, Laurent;
- Fornace, Albert J.;
- Hinman, Lois;
- Huixiao Hong;
- Hunt, Ian;
- Jacobson-Kram, David;
- Jawaid, Ansar;
- Laurie, David;
- Lesko, Lawrence;
- Heng-Hong Li;
- Lindpaintner, Klaus
Publication type:
review
The MicroArray Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive models.
Published in:
Nature Biotechnology, 2010, v. 28, n. 8, p. 827, doi. 10.1038/nbt.1665
By:
- Shi, Leming;
- Campbell, Gregory;
- Jones, Wendell D;
- Campagne, Fabien;
- Wen, Zhining;
- Walker, Stephen J;
- Su, Zhenqiang;
- Chu, Tzu-Ming;
- Goodsaid, Federico M;
- Pusztai, Lajos;
- Shaughnessy, John D;
- Oberthuer, André;
- Thomas, Russell S;
- Paules, Richard S;
- Fielden, Mark;
- Barlogie, Bart;
- Chen, Weijie;
- Du, Pan;
- Fischer, Matthias;
- Furlanello, Cesare
Publication type:
Article
Rat toxicogenomic study reveals analytical consistency across microarray platforms.
Published in:
Nature Biotechnology, 2006, v. 24, p. 1162, doi. 10.1038/nbt1238
By:
- Lei Guo;
- Lobenhofer, Edward K.;
- Wang, Charles;
- Shippy, Richard;
- Harris, Stephen C.;
- Lu Zhang;
- Nan Mei;
- Tao Chen;
- Herman, Damir;
- Goodsaid, Federico M.;
- Hurban, Patrick;
- Phillips, Kenneth L.;
- Jun Xu;
- Xutao Deng;
- Sun, Yongming Andrew;
- Weida Tong;
- Yvonne P.Dragan;
- Leming Shi
Publication type:
Article
The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements.
Published in:
Nature Biotechnology, 2006, v. 24, p. 1151, doi. 10.1038/nbt1239
By:
- Shi, Leming;
- Reid, Laura H.;
- Jones, Wendell D.;
- Shippy, Richard;
- Warrington, Janet A.;
- Baker, Shawn C.;
- Collins, Patrick J.;
- de Longueville, Francoise;
- Kawasaki, Ernest S.;
- Kathleen Y.Lee;
- Yuling Luo;
- Sun, Yongming Andrew;
- Willey, James C.;
- Setterquist, Robert A.;
- Fischer, Gavin M.;
- Tong, Weida;
- Dragan, Yvonne P.;
- Dix, David J.;
- Frueh, Felix W.;
- Goodsaid, Federico M.
Publication type:
Article
The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements.
Published in:
Nature Biotechnology, 2006, v. 24, n. 9, p. 1151, doi. 10.1038/nbt1239
By:
- Shi, Leming;
- Reid, Laura H.;
- Jones, Wendell D.;
- Shippy, Richard;
- Warrington, Janet A.;
- Baker, Shawn C.;
- Collins, Patrick J.;
- de Longueville, Francoise;
- Kawasaki, Ernest S.;
- Lee, Kathleen Y.;
- Luo, Yuling;
- Sun, Yongming Andrew;
- Willey, James C.;
- Setterquist, Robert A.;
- Fischer, Gavin M.;
- Tong, Weida;
- Dragan, Yvonne P.;
- Dix, David J.;
- Frueh, Felix W.;
- Goodsaid, Federico M.
Publication type:
Article
Rat toxicogenomic study reveals analytical consistency across microarray platforms.
Published in:
Nature Biotechnology, 2006, v. 24, n. 9, p. 1162, doi. 10.1038/nbt1238
By:
- Guo, Lei;
- Lobenhofer, Edward K.;
- Wang, Charles;
- Shippy, Richard;
- Harris, Stephen C.;
- Zhang, Lu;
- Mei, Nan;
- Chen, Tao;
- Herman, Damir;
- Goodsaid, Federico M.;
- Hurban, Patrick;
- Phillips, Kenneth L.;
- Xu, Jun;
- Deng, Xutao;
- Sun, Yongming Andrew;
- Tong, Weida;
- Dragan, Yvonne P.;
- Shi, Leming
Publication type:
Article
The balance of reproducibility, sensitivity, and specificity of lists of differentially expressed genes in microarray studies.
Published in:
BMC Bioinformatics, 2008, v. 9, p. 1, doi. 10.1186/1471-2105-9-S9-S10
By:
- Leming Shi;
- Jones, Wendell D.;
- Jensen, Roderick V.;
- Harris, Stephen C.;
- Perkins, Roger G.;
- Goodsaid, Federico M.;
- Lei Guo;
- Croner, Lisa J.;
- Boysen, Cecilie;
- Hong Fang;
- Feng Qian;
- Amur, Shashi;
- Wenjun Bao;
- Barbacioru, Catalin C.;
- Bertholet, Vincent;
- Cao, Xiaoxi Megan;
- Tzu-Ming Chu;
- Collins, Patrick J.;
- Xiao-hui Fan;
- Frueh, Felix W.
Publication type:
Article
Cross-platform comparability of microarray technology: Intra-platform consistency and appropriate data analysis procedures are essential.
Published in:
BMC Bioinformatics, 2005, v. 6, p. S12, doi. 10.1186/1471-2105-6-S2-S12
By:
- Shi, Leming;
- Tong, Weida;
- Fang, Hong;
- Scherf, Uwe;
- Han, Jing;
- Puri, Raj K.;
- Frueh, Felix W.;
- Goodsaid, Federico M.;
- Guo, Lei;
- Su, Zhenqiang;
- Han, Tao;
- Fuscoe, James C.;
- Xu, Z. Alex;
- Patterson, Tucker A.;
- Hong, Huixiao;
- Xie, Qian;
- Perkins, Roger G.;
- Chen, James J.;
- Casciano, Daniel A.
Publication type:
Article
Microarray scanner calibration curves: characteristics and implications.
Published in:
BMC Bioinformatics, 2005, v. 6, p. S11, doi. 10.1186/1471-2105-6-S2-S11
By:
- Shi, Leming;
- Tong, Weida;
- Su, Zhenqiang;
- Han, Tao;
- Han, Jing;
- Puri, Raj K.;
- Fang, Hong;
- Frueh, Felix W.;
- Goodsaid, Federico M.;
- Guo, Lei;
- Branham, William S.;
- Chen, James J.;
- Xu, Z. Alex;
- Harris, Stephen C.;
- Hong, Huixiao;
- Xie, Qian;
- Perkins, Roger G.;
- Fuscoe, James C.
Publication type:
Article
Translational Medicine and the Value of Biomarker Qualification.
Published in:
Science Translational Medicine, 2010, v. 2, n. 47, p. 1, doi. 10.1126/scitranslmed.3001040
By:
- Goodsaid, Federico M.;
- Mendrick, Donna L.
Publication type:
Article
Modulation of Clopidogrel Pharmacodynamic Response.
Published in:
Pharmacotherapy, 2008, v. 28, n. 12, p. 1423, doi. 10.1592/phco.28.12.1423
By:
- Goodsaid, Federico M.
Publication type:
Article
The Labyrinth of Product Development and Regulatory Approvals in Liquid Biopsy Diagnostics.
Published in:
CTS: Clinical & Translational Science, 2019, v. 12, n. 5, p. 431, doi. 10.1111/cts.12657
By:
- Goodsaid, Federico M.
Publication type:
Article
Biomarkers in Peripheral Blood Associated with Vascular Injury in Sprague-Dawley Rats Treated with the Phosphodiesterase IV Inhibitors SCH 351591 or SCH 534385.
Published in:
Toxicologic Pathology, 2008, v. 36, n. 6, p. 840, doi. 10.1177/0192623308322310
By:
- WEAVER, JAMES L.;
- SNYDER, RONALD;
- KNAPTON, ALAN;
- HERMAN, EUGENE H.;
- HONCHEL, RONALD;
- MILLER, TERRY;
- ESPANDIARI, PARVANEH;
- SMITH, ROGER;
- YI-ZHONG GU;
- GOODSAID, FEDERICO M.;
- ROSENBLUM, IRWIN Y.;
- SISTARE, FRANK D.;
- JUN ZHANG;
- HANIG, JOSEPH
Publication type:
Article
Histopathology of Vascular Injury in Sprague-Dawley Rats Treated with Phosphodiesterase IV Inhibitor SCH 351591 or SCH 534385.
Published in:
Toxicologic Pathology, 2008, v. 36, n. 6, p. 827, doi. 10.1177/0192623308322308
By:
- JUN ZHANG;
- SNYDER, RONALD D.;
- HERMAN, EUGENE H.;
- KNAPTON, ALAN;
- HONCHEL, RONALD;
- MILLER, TERRY;
- ESPANDIARI, PARVANEH;
- GOODSAID, FEDERICO M.;
- ROSENBLUM, IRWIN Y.;
- HANIG, JOSEPH P.;
- SISTARE, FRANK D.;
- WEAVER, JAMES L.
Publication type:
Article

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