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Shashi Amur | Researchclopedia

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Shashi Amur

United States Food and Drug Administration

44

Works

4,419

Citations

25

h-index

31

i10-index

Research Topics

Biosimilars and Bioanalytical Methods Computational Drug Discovery Methods Hepatitis C virus research

Affiliations

Aichi University2002–2002

United States Food and Drug Administration2006–2020

Center for Drug Evaluation and Research2006–2020

Top Works

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

Leming Shi,Leming Shi,et al.

20062,162 citations

Pharmacogenetics and Drug Metabolism

Health Systems, Economic Evaluations, Quality of Life

The balance of reproducibility, sensitivity, and specificity of lists of differentially expressed genes in microarray studies

Leming Shi,Wendell Jones,et al.

2008401 citations

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,et al.

2008306 citations

Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization

Shashi Amur,LM LaVange,et al.

2015204 citations

Sex differences and genomics in autoimmune diseases

Shashi Amur,Ameeta Parekh,et al.

2011124 citations

Integration and Use of Biomarkers in Drug Development, Regulation and Clinical Practice: a US Regulatory Perspective

Shashi Amur,Felix W. Frueh,et al.

2008113 citations

Molecular and immunohistochemical characterization of the onset and resolution of human renal allograft ischemia-reperfusion injury

Steven C. Hoffmann,Robert L. Kampen,et al.

200298 citations

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

Steven P. Piccoli,Devangi Mehta,et al.

201992 citations

Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact

Federico Goodsaid,Shashi Amur,et al.

201087 citations