Russell Weiner

发表

Navigating the Rapids: The Development of Regulated Next-Generation Sequencing-Based Clinical Trial Assays and Companion Diagnostics

Russell Weiner, Saumya Pant, M. Marton, 2014, Front. Oncol..

Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays

Vinod P. Shah, C. T. Viswanathan, Jeffrey Sailstad, 2007 .

Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules

Binodh DeSilva, Russell Weiner, Marian Kelley, 2003, Pharmaceutical Research.

2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines.

Sam H Haidar, Lauren F. Stevenson, Lauren F Stevenson, 2012, Bioanalysis.

A clinical biomarker assay to quantitate thymic stromal lymphopoietin in human plasma at sub-pg/ml level.

T. Mcclanahan, R. de Waal Malefyt, Xuemei Zhao, 2015, Bioanalysis.

Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement

Viswanath Devanarayan, Russell Weiner, Chad Ray, 2006, Pharmaceutical Research.

An ultra-sensitive clinical biomarker assay: quantitation of thymus and activation-regulated chemokine in human plasma.

Xuemei Zhao, O. Laterza, Russell Weiner, 2014, Bioanalysis.

Characterization and development of a Luminex(®)-based assay for the detection of human IL-23.

Yan J. Zhang, R. Latek, Russell Weiner, 2010, Bioanalysis.

Influence of Pre-Analytical Factors on Thymus- and Activation-Regulated Chemokine Quantitation in Plasma

Xuemei Zhao, O. Laterza, Russell Weiner, 2015, Journal of circulating biomarkers.

Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays

C. T. Viswanathan, Patrick G. Swann, V. Shah, 2007, Pharmaceutical Research.

Development and validation of an ultra-sensitive method for the measurement of plasma renin activity in human plasma via LC-MS/MS.

O. Laterza, T. McAvoy, Russell Weiner, 2012, Bioanalysis.

Immunoassay-based measurement of clinical biomarkers for monitoring changes in nasal cavity.

Yan J. Zhang, Russell Weiner, P. Rhyne, 2009, Journal of pharmaceutical and biomedical analysis.

Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays

Vinod P. Shah, C. T. Viswanathan, Jeffrey Sailstad, 2007, The AAPS Journal.

Next Generation Sequencing (NGS)-Repeatability, Reproducibility and accuracy of commercially available Cancer Panels

M. Marton, P. Qiu, John Kang, 2021 .

Validation of Next Generation Sequencing Cancer Panels for Clinical Somatic Mutation Profiling-- Identification of Source of Variations and Artifacts using FFPE Tissues

M. Marton, P. Qiu, John Kang, 2014 .

Method Validation and Measurement of Biomarkers in Nonclinical and Clinical Samples in Drug Development: A Conference Report

H. Soares, R. Pietrusko, V. Quarmby, 2005, Pharmaceutical Research.

Translating Molecular Biomarkers into Clinical Assays

Russell Weiner, Marian Kelley, 2016, AAPS Advances in the Pharmaceutical Sciences Series.

Bioanalytical Method Validation for Macromolecules in Support of Pharmacokinetic Studies

Binodh DeSilva, David Lansky, Russell Weiner, 2005, Pharmaceutical Research.

Workshop on Bioanalytical Methods Validation for Macromolecules: Summary Report

Krys J. Miller, Michael Geier, Steve J. Swanson, 2001, Pharmaceutical Research.

Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance

Eric Woolf, Binodh DeSilva, Lauren Stevenson, 2014, The AAPS Journal.

Development and Validation of a Clinical Trial Patient Stratification Assay That Interrogates 27 Mutation Sites in MAPK Pathway Genes

M. Marton, Russell Weiner, S. Galuska, 2013, PloS one.

A candidate plasma protein classifier to identify Alzheimer's disease.

Hongyue Dai, Russell Weiner, Xuemei Zhao, 2014, Journal of Alzheimer's disease : JAD.

Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance

Lauren F. Stevenson, Sam H. Haidar, B. Desilva, 2015, The AAPS Journal.

Electrochemiluminescence in bioanalysis.

Yan J. Zhang, Russell Weiner, P. Rhyne, 2009, Bioanalysis.

Development and fit-for-purpose validation of a LC-MS/MS assay for fibrinogen peptide A quantitation in human plasma.

Michael E. Lassman, O. Laterza, Russell Weiner, 2014, Bioanalysis.

Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations

Anthony J. DeStefano, Russell Weiner, Marian Kelley, 2009, The AAPS Journal.

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

Guodong Chen, Mohammed Jemal, Russell Weiner, 2011, Analytical and Bioanalytical Chemistry.

Translational Biomarkers: from Preclinical to Clinical a Report of 2009 AAPS/ACCP Biomarker Workshop

W. Jusko, H. Eichler, F. Goodsaid, 2011, The AAPS Journal.

2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.

Stacy Ho, Eric Woolf, Binodh DeSilva, 2011, Bioanalysis.

Validation of next-generation sequencing cancer panels for clinical somatic mutation profilin: Identification of source of variations and artifacts using FFPE tissues.

M. Marton, P. Qiu, John Kang, 2014 .

Erratum: Translational biomarkers: From preclinical to clinical a report of 2009 AAPS/ACCP biomarker workshop (AAPS Journal DOI: 10.1208/s12248-011-9265-x)

W. Jusko, H. Eichler, F. Goodsaid, 2011 .

Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays

C. T. Viswanathan, Patrick G. Swann, V. Shah, 2007, The AAPS Journal.

2 Bioanalytical report writing

Kevin Bateman, Roger Hayes, Eric Woolf, 2022 .

Erratum to: Translational Biomarkers: from Preclinical to Clinical a Report of 2009 AAPS/ACCP Biomarker Workshop

W. Jusko, H. Eichler, F. Goodsaid, 2011, The AAPS Journal.