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Inhibition of sclerostin by monoclonal antibody increases bone formation, bone mass, and bone strength in aged male rats

Journal of bone and mineral research, 2010-12, Vol.25 (12), p.2647-2656

2010

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Impact of Anti-Drug Antibodies in Preclinical Pharmacokinetic Assessment

The AAPS journal, 2013-07, Vol.15 (3), p.856-863

2013

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Fundamentals of large-molecule protein therapeutic bioanalysis using ligand-binding assays

Bioanalysis, 2016, Vol.8 (1), p.11-17

Thway, Theingi M

2016

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A Simulation Approach to Evaluate the Impact of Patterns of Bioanalytical Bias Difference on the Outcome of Pharmacokinetic Similarity Studies

Clinical pharmacology and therapeutics, 2020-07, Vol.108 (1), p.107-115

2020

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Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies

Clinical pharmacology and therapeutics, 2020-01, Vol.107 (1), p.40-42

2020

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Role of Modeling and Simulation in the Development of Novel and Biosimilar Therapeutic Proteins

Journal of pharmaceutical sciences, 2019-01, Vol.108 (1), p.73-77

2019

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A survey of pharmacokinetic bioanalytical methods in biosimilar biological license applications for the assessment of target and antidrug antibody effects

Bioanalysis, 2021-09, Vol.13 (17), p.1323-1332

2021

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Non-clinical similarity of biosimilar ABP 798 with rituximab reference product

Biologicals, 2021-07, Vol.72, p.42-53

2021

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Measurement of Free Versus Total Therapeutic Monoclonal Antibody in Pharmacokinetic Assessment is Modulated by Affinity, Incubation Time, and Bioanalytical Platform

The AAPS journal, 2015-11, Vol.17 (6), p.1446-1454

2015

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Retrospective Analysis of Bioanalytical Method Validation Approaches in Biosimilar Biological Product Development

The AAPS journal, 2019-11, Vol.21 (6), p.105-105, Article 105

2019

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In Silico Evaluation of the Potential Impact of Bioanalytical Bias Difference between Two Therapeutic Protein Formulations for Pharmacokinetic Assessment in a Biocomparability Study

The AAPS journal, 2015-05, Vol.17 (3), p.684-690

2015

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Utility of a Bayesian Mathematical Model to Predict the Impact of Immunogenicity on Pharmacokinetics of Therapeutic Proteins

The AAPS journal, 2016-03, Vol.18 (2), p.424-431

2016

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Stability assessment in ligand-binding assays: a critical parameter for data integrity

Bioanalysis, 2015-01, Vol.7 (11), p.1315-1317

2015

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Assessment of Incurred Sample Reanalysis for Macromolecules to Evaluate Bioanalytical Method Robustness: Effects from Imprecision

The AAPS journal, 2011-06, Vol.13 (2), p.291-298

2011

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Validation of a microfluidic platform to measure total therapeutic antibodies and incurred sample reanalysis performance

Bioanalysis, 2014-01, Vol.6 (19), p.2623-2633

2014

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Model-based strategy for bioanalytical method comparison: Measurement of a soluble ligand as a biomarker

Journal of pharmaceutical and biomedical analysis, 2012-01, Vol.58 (25), p.65-70

2012

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Method transfer for ligand-binding assays: recommendations for best practice

Bioanalysis, 2011-09, Vol.3 (18), p.2143-2152

2011

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Experimental and statistical approaches in method cross-validation to support pharmacokinetic decisions

Journal of pharmaceutical and biomedical analysis, 2009-04, Vol.49 (3), p.613-618

2009

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Bioanalytical method requirements and statistical considerations in incurred sample reanalysis for macromolecules

Bioanalysis, 2010-09, Vol.2 (9), p.1587-1596

2010

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An activator protein-1 complex mediates epidermal growth factor regulation of equine glycoprotein α subunit expression in trophoblast cells

Biology of reproduction, 2002-09, Vol.67 (3), p.972-980

2002

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An Activator Protein-1 Complex Mediates Epidermal Growth Factor Regulation of Equine Glycoprotein α Subunit Expression in Trophoblast Cells1

Biology of reproduction, 2002-09, Vol.67 (3), p.972-980

2002

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Epidermal Growth Factor Regulation of Equine Glycoprotein Hormone α Subunit Expression in Trophoblast Cells1

Biology of reproduction, 2001-07, Vol.65 (1), p.197-203

2001

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Antibodies from preeclamptic patients stimulate increased intracellular Ca2+ mobilization through angiotensin receptor activation

Circulation (New York, N.Y.), 2004-09, Vol.110 (12), p.1612-1619

2004

Volltextzugriff (PDF)

Anti-CD117 (c-Kit) Monoclonal Antibodies Deplete Human Hematopoietic Stem Cells and Facilitate Their Replacement in Humanized NOD/SCID/IL2Rγ−/− Mice: A Non-Toxic Conditioning Regimen for Allotransplantation

Blood, 2012-11, Vol.120 (21), p.4099-4099

2012

Volltextzugriff (PDF)

An Activator Protein-1 Complex Mediates Epidermal Growth Factor Regulation of Equine Glycoprotein Î± Subunit Expression in Trophoblast Cells

Biology of reproduction, 2002-09, Vol.67 (3), p.972

2002

Volltextzugriff (PDF)

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Inhibition of sclerostin by monoclonal antibody increases bone formation, bone mass, and bone strength in aged male rats

Impact of Anti-Drug Antibodies in Preclinical Pharmacokinetic Assessment

Fundamentals of large-molecule protein therapeutic bioanalysis using ligand-binding assays

A Simulation Approach to Evaluate the Impact of Patterns of Bioanalytical Bias Difference on the Outcome of Pharmacokinetic Similarity Studies

Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies

Role of Modeling and Simulation in the Development of Novel and Biosimilar Therapeutic Proteins

A survey of pharmacokinetic bioanalytical methods in biosimilar biological license applications for the assessment of target and antidrug antibody effects

Non-clinical similarity of biosimilar ABP 798 with rituximab reference product

Measurement of Free Versus Total Therapeutic Monoclonal Antibody in Pharmacokinetic Assessment is Modulated by Affinity, Incubation Time, and Bioanalytical Platform

Retrospective Analysis of Bioanalytical Method Validation Approaches in Biosimilar Biological Product Development

In Silico Evaluation of the Potential Impact of Bioanalytical Bias Difference between Two Therapeutic Protein Formulations for Pharmacokinetic Assessment in a Biocomparability Study

Utility of a Bayesian Mathematical Model to Predict the Impact of Immunogenicity on Pharmacokinetics of Therapeutic Proteins

Stability assessment in ligand-binding assays: a critical parameter for data integrity

Assessment of Incurred Sample Reanalysis for Macromolecules to Evaluate Bioanalytical Method Robustness: Effects from Imprecision

Validation of a microfluidic platform to measure total therapeutic antibodies and incurred sample reanalysis performance

Model-based strategy for bioanalytical method comparison: Measurement of a soluble ligand as a biomarker

Method transfer for ligand-binding assays: recommendations for best practice

Experimental and statistical approaches in method cross-validation to support pharmacokinetic decisions

Bioanalytical method requirements and statistical considerations in incurred sample reanalysis for macromolecules

An activator protein-1 complex mediates epidermal growth factor regulation of equine glycoprotein α subunit expression in trophoblast cells

An Activator Protein-1 Complex Mediates Epidermal Growth Factor Regulation of Equine Glycoprotein α Subunit Expression in Trophoblast Cells1

Epidermal Growth Factor Regulation of Equine Glycoprotein Hormone α Subunit Expression in Trophoblast Cells1

Antibodies from preeclamptic patients stimulate increased intracellular Ca2+ mobilization through angiotensin receptor activation

Anti-CD117 (c-Kit) Monoclonal Antibodies Deplete Human Hematopoietic Stem Cells and Facilitate Their Replacement in Humanized NOD/SCID/IL2Rγ−/− Mice: A Non-Toxic Conditioning Regimen for Allotransplantation

An Activator Protein-1 Complex Mediates Epidermal Growth Factor Regulation of Equine Glycoprotein Î± Subunit Expression in Trophoblast Cells

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