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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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A phase 1 study to evaluate the safety and LDL cholesterol–lowering effects of RG7652, a fully human monoclonal antibody against proprotein convertase subtilisin/kexin type 9

Clinical cardiology (Mahwah, N.J.), 2017-07, Vol.40 (7), p.503-511

2017

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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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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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Pharmacokinetics and biodistribution of a human monoclonal antibody to oxidized LDL in cynomolgus monkey using PET imaging

PloS one, 2012-09, Vol.7 (9), p.e45116

2012

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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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Effects of RG7652, a Monoclonal Antibody Against PCSK9, on 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, 2017-05, Vol.119 (10), p.1576-1583

2017

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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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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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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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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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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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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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HGF as a circulating biomarker of onartuzumab treatment in patients with advanced solid tumors

Molecular cancer therapeutics, 2013-06, Vol.12 (6), p.1122-1130

2013

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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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Reversible phosphorylation control of skeletal muscle pyruvate kinase and phosphofructokinase during estivation in the spadefoot toad, Scaphiopus couchii

Molecular and cellular biochemistry, 1999-05, Vol.195 (1-2), p.173-181

1999

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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, 2017

2017

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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

Minipig as a potential translatable model for monoclonal antibody pharmacokinetics after intravenous and subcutaneous administration

A phase 1 study to evaluate the safety and LDL cholesterol–lowering effects of RG7652, a fully human monoclonal antibody against proprotein convertase subtilisin/kexin type 9

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

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

Pharmacokinetics and biodistribution of a human monoclonal antibody to oxidized LDL in cynomolgus monkey using PET imaging

Translational strategies in drug development for knee osteoarthritis

Effects of RG7652, a Monoclonal Antibody Against PCSK9, on 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)

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

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

Effects of altered FcγR binding on antibody pharmacokinetics in cynomolgus monkeys

Recommendations for Selection and Characterization of Protein Biomarker Assay Calibrator Material

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

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)

HGF as a circulating biomarker of onartuzumab treatment in patients with advanced solid tumors

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

Utilizing design of experiments to characterize assay robustness

Reversible phosphorylation control of skeletal muscle pyruvate kinase and phosphofructokinase during estivation in the spadefoot toad, Scaphiopus couchii

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)

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