Shashi Amur

发表

Sex differences and genomics in autoimmune diseases.

S. Amur, A. Parekh, P. Mummaneni, 2012, Journal of autoimmunity.

Pharmacogenomic Biomarker Information in Drug Labels Approved by the United States Food and Drug Administration: Prevalence of Related Drug Use

Shashi Amur, R. Verbrugge, F. Frueh, 2008, Pharmacotherapy.

2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).

Hao Jiang, Amanda Wilson, Eric Woolf, 2017, Bioanalysis.

Current Status and Future Opportunities in Lung Precision Medicine Research with a Focus on Biomarkers. An American Thoracic Society/National Heart, Lung, and Blood Institute Research Statement

E. Burchard, J. Galanter, J. Clancy, 2018, American journal of respiratory and critical care medicine.

Biomarkers for the Development of New Medications for Cocaine Dependence

S. Amur, F. Moeller, S. Hemby, 2014, Neuropsychopharmacology.

Translational Safety Biomarkers of Kidney Injury.

S. Amur, Rupesh P. Amin, K. Vlasakova, 2019, Seminars in nephrology.

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

S. Amur, I. Zineh, J. Woodcock, 2015, Clinical pharmacology and therapeutics.

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

Catalin C. Barbacioru, Leming Shi, Hong Fang, 2008, BMC Bioinformatics.

Biomarkers for Smoking Cessation

S. David, S. Amur, G. Uhl, 2013, Clinical pharmacology and therapeutics.

REVIEWTHEME : GENERAL Integration and use of biomarkers in drug development , regulation and clinical practice : a US regulatory perspective

F. Frueh, S. Amur, Shiew-Mei Huang, 2008 .

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, B

Yow-Ming C Wang, Andrew P Mayer, M. Fiscella, 2019, Bioanalysis.

2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).

Eric Woolf, Akiko Ishii-Watabe, Naidong Weng, 2018, Bioanalysis.

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).

Neil Henderson, Rong Zeng, Renuka Pillutla, 2018, Bioanalysis.

2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).

Sam H Haidar, Lauren F. Stevenson, Barry van der Strate, 2017, Bioanalysis.

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

Jiri Aubrecht, Weida Tong, Huixiao Hong, 2010, Nature Reviews Drug Discovery.

Patient-Centered Therapy Development for Myotonic Dystrophy: Report of the Myotonic Dystrophy Foundation–Sponsored Workshop

J. Carulli, Sharon E. Hesterlee, R. Moxley, 2017, Therapeutic innovation & regulatory science.

Building a roadmap to biomarker qualification: challenges and opportunities.

Susan McCune, S. Amur, Aloka G Chakravarty, 2015, Biomarkers in medicine.

The FDA in the 21st Century: How Is the FDA Responding to the New World? A Focus on Cardiovascular Drug Development.

R. Califf, S. Amur, N. Stockbridge, 2017, JACC. Heart failure.

Catalyzing the critical path initiative: FDA's progress in drug development activities

S. Amur, J. Woodcock, S. Buckman-Garner, 2015, Clinical pharmacology and therapeutics.

Evaluating the Use of KIM‐1 in Drug Development and Research Following FDA Qualification

S. Amur, J. Ix, A. Thompson, 2018, Clinical pharmacology and therapeutics.

New genetic discoveries and treatment for hepatitis C.

I. Zineh, M. Pacanowski, Shashi Amur, 2012, JAMA.

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

S. Amur, A. Kirk, P. Blair, 2002, Transplantation.

Update on the clinical pharmacogenomics of organ transplantation.

S. Amur, G. Burckart, Shashi Amur, 2010, Pharmacogenomics.