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Preclinical pharmacokinetics, pharmacodynamics, tissue distribution, and tumor penetration of anti-PD-L1 monoclonal antibody, an immune checkpoint inhibitor

mAbs, 2016-04, Vol.8 (3), p.593-603

2016

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Mitogen-activated protein kinases: new signaling pathways functioning in cellular responses to environmental stress

Journal of experimental biology, 2003-04, Vol.206 (Pt 7), p.1107-1115

2003

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Biomarker context-of-use: how organizational design can impact the implementation of the appropriate biomarker assay strategy

Bioanalysis, 2022-07, Vol.14 (13), p.911-917

2022

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Hybrid liquid chromatography high resolution and accuracy mass spectrometry approach for quantification of antibody-drug conjugates at the intact protein level in biological samples

European journal of pharmaceutical sciences, 2023-09, Vol.188, p.106502-106502, Article 106502

2023

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Critical reagent considerations for immunogenicity assay development for bispecific biotherapeutic candidates

Bioanalysis, 2024-07, Vol.16 (15), p.781-10

2024

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R399E, A Mutated Form of Growth and Differentiation Factor 5, for Disease Modification of Osteoarthritis

Arthritis & rheumatology (Hoboken, N.J.), 2023-03, Vol.75 (3), p.375-386

2023

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Implementing fit-for-purpose biomarker assay approaches: a bioanalytical perspective

Bioanalysis, 2016-06, Vol.8 (12), p.1221-1223

Cowan, Kyra J

2016

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Translational strategies in drug development for knee osteoarthritis

Drug discovery today, 2020-06, Vol.25 (6), p.1054-1064

2020

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A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays

Bioanalysis, 2024-08, Vol.16 (16), p.835-842

2024

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Update to the European Bioanalysis Forum recommendation on biomarkers assays; bringing context of use into practice

Bioanalysis, 2020-10, Vol.12 (20), p.1427-1437

2020

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Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development

The AAPS journal, 2016-01, Vol.18 (1), p.1-14

2016

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The European Bioanalysis Forum recommendation on establishing appropriate drug tolerance levels in antidrug antibody assays

Bioanalysis, 2024, Vol.16 (17-18), p.915-921

2024

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Effects of altered FcγR binding on antibody pharmacokinetics in cynomolgus monkeys

mAbs, 2013-11, Vol.5 (6), p.896-903

2013

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Re-thinking the current paradigm for clinical immunogenicity assessment: an update from the discussion in the European Bioanalysis Forum

Bioanalysis, 2024-09, Vol.16 (17-18), p.905-913

2024

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Neutralizing Antibody Sample Testing and Report Harmonization

The AAPS journal, 2024-07, Vol.26 (4), p.80, Article 80

2024

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Correction to: Neutralizing Antibody Sample Testing and Report Harmonization

The AAPS journal, 2024-09, Vol.26 (5), p.98, Article 98

2024

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A strategic approach to nonclinical immunogenicity assessment: a recommendation from the European Bioanalysis Forum

Bioanalysis, 2021-04, Vol.13 (7), p.537-549

2021

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Recommendations for Selection and Characterization of Protein Biomarker Assay Calibrator Material

The AAPS journal, 2017-11, Vol.19 (6), p.1550-1563

2017

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Impact of SPR biosensor assay configuration on antibody: Neonatal Fc receptor binding data

mAbs, 2017-02, Vol.9 (2), p.319-332

2017

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On assay robustness: the importance of early determination and science-driven decision-making

Bioanalysis, 2013-06, Vol.5 (11), p.1317-1319

Cowan, Kyra J

2013

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Corrigendum to ‘Effects of RG7652, a Monoclonal Antibody Against PCSK9, on Low-Density Lipoprotein Cholesterol (LDL-C), LDL-C Subfractions, and Inflammatory Biomarkers in Patients at High Risk of or with Established Coronary Heart Disease (From the Phase 2 EQUATOR Study)’ The American Journal of Cardiology 119 (2017) 1576–1583

The American journal of cardiology, 2018-08, Vol.122 (3), p.527-527

2018

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2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity)

Bioanalysis, 2016-12, Vol.8 (23), p.2475-2496

2016

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Targeting oxidized LDL improves insulin sensitivity and immune cell function in obese Rhesus macaques

Molecular metabolism (Germany), 2013-08, Vol.2 (3), p.256-269

2013

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Utilizing design of experiments to characterize assay robustness

Bioanalysis, 2012-09, Vol.4 (17), p.2127-2139

2012

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Preclinical pharmacokinetics, pharmacodynamics, tissue distribution, and tumor penetration of anti-PD-L1 monoclonal antibody, an immune checkpoint inhibitor

Mitogen-activated protein kinases: new signaling pathways functioning in cellular responses to environmental stress

Biomarker context-of-use: how organizational design can impact the implementation of the appropriate biomarker assay strategy

Hybrid liquid chromatography high resolution and accuracy mass spectrometry approach for quantification of antibody-drug conjugates at the intact protein level in biological samples

Critical reagent considerations for immunogenicity assay development for bispecific biotherapeutic candidates

R399E, A Mutated Form of Growth and Differentiation Factor 5, for Disease Modification of Osteoarthritis

Implementing fit-for-purpose biomarker assay approaches: a bioanalytical perspective

Translational strategies in drug development for knee osteoarthritis

A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays

Update to the European Bioanalysis Forum recommendation on biomarkers assays; bringing context of use into practice

Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development

The European Bioanalysis Forum recommendation on establishing appropriate drug tolerance levels in antidrug antibody assays

Effects of altered FcγR binding on antibody pharmacokinetics in cynomolgus monkeys

Re-thinking the current paradigm for clinical immunogenicity assessment: an update from the discussion in the European Bioanalysis Forum

Neutralizing Antibody Sample Testing and Report Harmonization

Correction to: Neutralizing Antibody Sample Testing and Report Harmonization

A strategic approach to nonclinical immunogenicity assessment: a recommendation from the European Bioanalysis Forum

Recommendations for Selection and Characterization of Protein Biomarker Assay Calibrator Material

Anti-drug Antibody Sample Testing and Reporting Harmonization

Impact of SPR biosensor assay configuration on antibody: Neonatal Fc receptor binding data

On assay robustness: the importance of early determination and science-driven decision-making

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity)

Targeting oxidized LDL improves insulin sensitivity and immune cell function in obese Rhesus macaques

Utilizing design of experiments to characterize assay robustness

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