S
Shashi Amur
Researcher at Center for Drug Evaluation and Research
Publications - 29
Citations - 3707
Shashi Amur is an academic researcher from Center for Drug Evaluation and Research. The author has contributed to research in topics: Drug development & Organ transplantation. The author has an hindex of 18, co-authored 29 publications receiving 3546 citations. Previous affiliations of Shashi Amur include Food and Drug Administration.
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Journal ArticleDOI
The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements
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 Setterquist,Gavin M. Fischer,Weida Tong,Yvonne P. Dragan,David J. Dix,Felix W. Frueh,Federico Goodsaid,Damir Herman,Roderick V. Jensen,Charles D. Johnson,Edward K. Lobenhofer,Raj K. Puri,Uwe Scherf,Jean Thierry-Mieg,Charles Wang,Michael A Wilson,Paul K. Wolber,Lu Zhang,William Slikker,Shashi Amur,Wenjun Bao,Catalin Barbacioru,Anne Bergstrom Lucas,Vincent Bertholet,Cecilie Boysen,Bud Bromley,Donna Brown,Alan Brunner,Roger D. Canales,Xiaoxi Megan Cao,Thomas A. Cebula,James J. Chen,Jing Cheng,Tzu Ming Chu,Eugene Chudin,John F. Corson,J. Christopher Corton,Lisa J. Croner,Christopher Davies,Timothy Davison,Glenda C. Delenstarr,Xutao Deng,David Dorris,Aron Charles Eklund,Xiaohui 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 Harbottle,Stephen C. Harris,Eli Hatchwell,Craig A. Hauser,Susan D. Hester,Huixiao Hong,Patrick Hurban,Scott A. Jackson,Hanlee P. Ji,Charles R. Knight,Winston Patrick Kuo,J. Eugene LeClerc,Shawn Levy,Quan Zhen Li,Chunmei Liu,Ying Liu,Michael Lombardi,Yunqing Ma,Scott R. Magnuson,Botoul Maqsodi,Timothy K. McDaniel,Nan Mei,Ola Myklebost,Baitang Ning,Natalia Novoradovskaya,Michael S. Orr,Terry Osborn,Adam Papallo,Tucker A. Patterson,Roger Perkins,Elizabeth Herness Peters,Ron L. 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,Russell D. Wolfinger,Alexander Wong,Jie Wu,Chunlin Xiao,Qian Xie,Jun Xu,Wen Yang,Liang Zhang,Sheng Zhong,Yaping Zong +136 more
TL;DR: This study describes the experimental design and probe mapping efforts behind the MicroArray Quality Control project and shows intraplatform consistency across test sites as well as a high level of interplatform concordance in terms of genes identified as differentially expressed.
Journal ArticleDOI
The balance of reproducibility, sensitivity, and specificity of lists of differentially expressed genes in microarray studies
Leming Shi,Wendell D. Jones,Roderick V. Jensen,Stephen C. Harris,Roger Perkins,Federico Goodsaid,Lei Guo,Lisa J. Croner,Cecilie Boysen,Hong Fang,Feng Qian,Shashi Amur,Wenjun Bao,Catalin Barbacioru,Vincent Bertholet,Xiaoxi Megan Cao,Tzu Ming Chu,Patrick J. Collins,Xiaohui Fan,Xiaohui Fan,Felix W. Frueh,James C. Fuscoe,Xu Guo,Jing Han,Damir Herman,Huixiao Hong,Ernest S. Kawasaki,Quan Zhen Li,Yuling Luo,Yunqing Ma,Nan Mei,Ron L. Peterson,Raj K. Puri,Richard Shippy,Zhenqiang Su,Yongming Andrew Sun,Hongmei Sun,Brett T. Thorn,Yaron Turpaz,Charles Wang,Sue Jane Wang,Janet A. Warrington,James C. Willey,Jie Wu,Qian Xie,Liang Zhang,Lu Zhang,Sheng Zhong,Russell D. Wolfinger,Weida Tong +49 more
TL;DR: The results provide practical guidance to choose the appropriate FC and P-value cutoffs when selecting a given number of DEGs and recommend the use of FC-ranking plus a non-stringent P cutoff as a straightforward and baseline practice in order to generate more reproducible DEG lists.
Journal ArticleDOI
Pharmacogenomic Biomarker Information in Drug Labels Approved by the United States Food and Drug Administration: Prevalence of Related Drug Use
Felix W. Frueh,Shashi Amur,Padmaja Mummaneni,Robert S. Epstein,Ronald E. Aubert,Teresa M. DeLuca,Robert R. Verbrugge,Gilbert J. Burckart,Lawrence J. Lesko +8 more
TL;DR: To review the labels of United States Food and Drug Administration‐approved drugs to identify those that contain pharmacogenomic biomarker information, and to collect prevalence information on the use of those drugs for which pharmacogenetic information is included in the drug labeling.
Journal ArticleDOI
Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization.
TL;DR: Various types of biomarkers that can be useful in drug development and evidentiary considerations that are important for qualification are described.
Journal ArticleDOI
Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective
TL;DR: The US FDA organized workshops, issued guidances, established a voluntary submission process, developed online educational tools, and strives to ensure the integration of biomarkers into drug labels, for example, via the update of existing labels, or the inclusion of appropriate language in new drug labels.