QA/QC issues to aid regulatory acceptance of microarray gene expression data.
作者： James C. Fuscoe , Weida Tong , Leming Shi
DOI: 10.1002/EM.20293
关键词:
摘要: The U.S. Food and Drug Administration is responsible for (1) promoting protecting public health by assuring the safety effectiveness of medicines medical devices (2) advancing helping to speed innovations that make foods safer, more effective, affordable. genomics revolution has dramatically increased our knowledge basic biology but this not resulted in expected acceleration new product development. Agency's Critical Path New Medical Products stresses tools are needed address pipeline problem. Microarray technology one these promising although questions have risen about reproducibility measurements. Quality Control (MAQC) Project was initiated FDA scientists issue. This large project, which evaluated reference RNA samples on seven microarray platforms, found good intralaboratory repeatability interlaboratory reproducibility. In addition, there high cross-platform consistency. All data available free cost proficiency testing. Thus, current appears provide both reliability consistency regulatory submissions.
sci-hub.se 参考文章(18)
J. Couzin, GENOMICS: Microarray Data Reproduced, But Some Concerns Remain Science. ,vol. 313, pp. 1559a- 1559a ,(2006) , 10.1126/SCIENCE.313.5793.1559A
Ismail Kola, John Landis, Can the pharmaceutical industry reduce attrition rates? Nature Reviews Drug Discovery. ,vol. 3, pp. 711- 716 ,(2004) , 10.1038/NRD1470
Leming Shi, Weida Tong, Hong Fang, Uwe Scherf, Jing Han, Raj K Puri, Felix W Frueh, Federico M Goodsaid, Lei Guo, Zhenqiang Su, Tao Han, James C Fuscoe, Z aAlex Xu, Tucker A Patterson, Huixiao Hong, Qian Xie, Roger G Perkins, James J Chen, Daniel A Casciano, Cross-platform comparability of microarray technology: intra-platform consistency and appropriate data analysis procedures are essential. BMC Bioinformatics. ,vol. 6, pp. 1- 14 ,(2005) , 10.1186/1471-2105-6-S2-S12
Evelyn Strauss, Arrays of Hope Cell. ,vol. 127, pp. 657- 659 ,(2006) , 10.1016/J.CELL.2006.11.005
Felix W Frueh, Impact of microarray data quality on genomic data submissions to the FDA. Nature Biotechnology. ,vol. 24, pp. 1105- 1107 ,(2006) , 10.1038/NBT0906-1105
E. Marshall, Getting the Noise Out of Gene Arrays Science. ,vol. 306, pp. 630- 631 ,(2004) , 10.1126/SCIENCE.306.5696.630
Veronique Kiermer, Microarray quality in the spotlight again Nature Methods. ,vol. 3, pp. 772- 772 ,(2006) , 10.1038/NMETH1006-772
Richard Shippy, Stephanie Fulmer-Smentek, Roderick V Jensen, Wendell D Jones, Paul K Wolber, Charles D Johnson, P Scott Pine, Cecilie Boysen, Xu Guo, Eugene Chudin, Yongming Andrew Sun, James C Willey, Jean Thierry-Mieg, Danielle Thierry-Mieg, Robert A Setterquist, Mike Wilson, Anne Bergstrom Lucas, Natalia Novoradovskaya, Adam Papallo, Yaron Turpaz, Shawn C Baker, Janet A Warrington, Leming Shi, Damir Herman, Using RNA sample titrations to assess microarray platform performance and normalization techniques Nature Biotechnology. ,vol. 24, pp. 1123- 1131 ,(2006) , 10.1038/NBT1241
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, Federico 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, S Zhong, Y Zong, W Slikker Jr, None, The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements Nature Biotechnology. ,vol. 24, pp. 1151- 1161 ,(2006) , 10.1038/NBT1239
Linda Sage, Do microarrays measure up? | Correlations a key to advancing chemical imaging Analytical Chemistry. ,vol. 78, pp. 7358- 7360 ,(2006) , 10.1021/AC0694775