Publications by authors named "Russell Weiner"

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2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines ( - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies).
Olga Kholmanskikh, Yow-Ming Wang, Sarah Hersey, Meenu Wadhwa, Katherine Block, Russell Weiner

Bioanalysis· June 2024

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Development of a Prototype Immunohistochemistry Assay to Measure Programmed Death Ligand-1 Expression in Tumor Tissue.
Marisa Dolled-Filhart, Darren Locke, Tiffany Murphy, Frank Lynch, Jennifer H Yearley, Russell Weiner

Arch Pathol Lab Med· November 2016

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Prognostic Significance of PD-L1 in Patients with Non-Small Cell Lung Cancer: A Large Cohort Study of Surgically Resected Cases.
Jong-Mu Sun, Wei Zhou, Yoon-La Choi, So-Jung Choi, Se Eun Kim, Russell Weiner

J Thorac Oncol· July 2016

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A clinical biomarker assay to quantitate thymic stromal lymphopoietin in human plasma at sub-pg/ml level.
Xuemei Zhao, Gulesi Ayanoglu, Melissa Bilardello, Laurence Fayadat-Dilman, Jeffrey H Zhang, Russell Weiner

Bioanalysis· December 2015

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Influence of Pre-Analytical Factors on Thymus- and Activation-Regulated Chemokine Quantitation in Plasma.
Xuemei Zhao, Liliana Delgado, Russell Weiner, Omar F Laterza

J Circ Biomark· October 2015

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A candidate plasma protein classifier to identify Alzheimer's disease.
Xuemei Zhao, Serguei Lejnine, Jeffrey Spond, Chunsheng Zhang, T C Ramaraj, Russell Weiner

J Alzheimers Dis· July 2015

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Development and fit-for-purpose validation of a LC-MS/MS assay for fibrinogen peptide A quantitation in human plasma.
Mingxiang Lin, Michael E Lassman, Russell Weiner, Omar F Laterza

Bioanalysis· July 2015

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Workshop report: Crystal City V--quantitative bioanalytical method validation and implementation: the 2013 revised FDA guidance.
Brian Booth, Mark E Arnold, Binodh DeSilva, Lakshmi Amaravadi, Sherri Dudal, Russell Weiner

AAPS J· March 2015

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Development and validation of a clinical trial patient stratification assay that interrogates 27 mutation sites in MAPK pathway genes.
Ken C N Chang, Stefan Galuska, Russell Weiner, Matthew J Marton

PLoS One· June 2014

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Practical guidance for implementing predictive biomarkers into early phase clinical studies.
Matthew J Marton, Russell Weiner

Biomed Res Int· June 2014

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Navigating the rapids: the development of regulated next-generation sequencing-based clinical trial assays and companion diagnostics.
Saumya Pant, Russell Weiner, Matthew J Marton

Front Oncol· June 2014

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An ultra-sensitive clinical biomarker assay: quantitation of thymus and activation-regulated chemokine in human plasma.
Xuemei Zhao, Liliana Delgado, Russell Weiner, Omar F Laterza

Bioanalysis· April 2014

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Development and validation of an ultra-sensitive method for the measurement of plasma renin activity in human plasma via LC-MS/MS.
Derek L Chappell, Thomas McAvoy, Barbra Weiss, Russell Weiner, Omar F Laterza

Bioanalysis· December 2012

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2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines.
Binodh DeSilva, Fabio Garofolo, Mario Rocci, Suzanne Martinez, Isabelle Dumont, Russell Weiner

Bioanalysis· September 2012

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Attribution of the discrepancy between ELISA and LC-MS/MS assay results of a PEGylated scaffold protein in post-dose monkey plasma samples due to the presence of anti-drug antibodies.
Shujie J Wang, Steven T Wu, Jochem Gokemeijer, Aberra Fura, Murli Krishna, Russell Weiner

Anal Bioanal Chem· January 2012

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2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.
Fabio Garofolo, Mario L Rocci, Isabelle Dumont, Suzanne Martinez, Steve Lowes, Russell Weiner

Bioanalysis· September 2011

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Translational biomarkers: from preclinical to clinical a report of 2009 AAPS/ACCP Biomarker Workshop.
Jane P F Bai, Robert Bell, ShaAvhree Buckman, Gilbert J Burckart, Hans-Georg Eichler, Russell Weiner

AAPS J· June 2011

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Characterization and development of a Luminex(®)-based assay for the detection of human IL-23.
Giovanni Rizzi, Yan J Zhang, Robert Latek, Russell Weiner, Paul W Rhyne

Bioanalysis· September 2010

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Immunoassay-based measurement of clinical biomarkers for monitoring changes in nasal cavity.
Yan J Zhang, Sherri Luroe, Frank Schieber, Joan Kelsey, Fizal Nabbie, Russell Weiner

J Pharm Biomed Anal· December 2009

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Electrochemiluminescence in bioanalysis.
Paul W Rhyne, Oi T Wong, Yan J Zhang, Russell S Weiner

Bioanalysis· August 2009

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Workshop report and follow-up--AAPS Workshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples--implications of Crystal City recommendations.
Douglas M Fast, Marian Kelley, C T Viswanathan, Jacqueline O'Shaughnessy, S Peter King, Russell Weiner

AAPS J· June 2009

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Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays.
C T Viswanathan, Surendra Bansal, Brian Booth, Anthony J DeStefano, Mark J Rose, Russell Weiner

Pharm Res· October 2007

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Fit-for-purpose method development and validation for successful biomarker measurement.
Jean W Lee, Viswanath Devanarayan, Yu Chen Barrett, Russell Weiner, John Allinson

Pharm Res· February 2006

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Bioanalytical method validation for macromolecules in support of pharmacokinetic studies.
JoMarie Smolec, Binodh DeSilva, Wendell Smith, Russell Weiner, Marian Kelly

Pharm Res· September 2005

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Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules.
Binodh DeSilva, Wendell Smith, Russell Weiner, Marian Kelley, JoMarie Smolec

Pharm Res· November 2003

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