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Pre-existing anti–polyethylene glycol antibody linked to first-exposure allergic reactions to pegnivacogin, a PEGylated RNA aptamer

Journal of allergy and clinical immunology, 2016-05, Vol.137 (5), p.1610-1613.e7

2016

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Pre-existing anti-PEG antibodies are associated with severe immediate allergic reactions to pegnivacogin, a PEGylated aptamer

Journal of allergy and clinical immunology, 2016-12, Vol.138 (6), p.1712-1715

2016

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Foreword to J Burrows’ Articles

Bioanalysis, 2013-04, Vol.5 (8), p.933-933

Sailstad, Jeffrey M

2013

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Application of commercial research-grade biomarker assays in drug development: is it time to create 'pharmaceutical-grade' kits?

Bioanalysis, 2012-10, Vol.4 (20), p.2427-2430

2012

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Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift

The AAPS journal, 2019-07, Vol.21 (5), p.89, Article 89

2019

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Incurred sample reanalysis: failures in macromolecule analysis--insight into possible causes

Bioanalysis, 2011-05, Vol.3 (9), p.1001-1006

2011

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Calibration Curves in Quantitative Ligand Binding Assays: Recommendations and Best Practices for Preparation, Design, and Editing of Calibration Curves

The AAPS journal, 2018-01, Vol.20 (1), p.22-22, Article 22

2018

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Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays

Pharmaceutical research, 2007-10, Vol.24 (10), p.1962-1973

2007

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

The AAPS journal, 2007-02, Vol.9 (1), p.E30-E42

2007

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Insights in the application of research-grade diagnostic kits for biomarker assessments in support of clinical drug development: Bioanalysis of circulating concentrations of soluble receptor activator of nuclear factor κB ligand

Journal of pharmaceutical and biomedical analysis, 2008-12, Vol.48 (5), p.1282-1289

2008

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Understanding and mitigating impact of immunogenicity on pharmacokinetic assays

Bioanalysis, 2011-08, Vol.3 (16), p.1799-1803

2011

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A Phase I and Pharmacokinetic Study of 1843U89, a Noncompetitive Inhibitor of Thymidylate Synthase, in Patients with Advanced Solid Malignancies

Clinical cancer research, 2001-07, Vol.7 (7), p.1901-1911

2001

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Insights in the application of research-grade diagnostic kits for biomarker assessments in support of clinical drug development: bioanalysis of circulating concentrations of soluble receptor activator of nuclear factor kappaB ligand

Journal of pharmaceutical and biomedical analysis, 2008-12, Vol.48 (5), p.1282-1289

2008

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Insights in the application of research-grade diagnostic kits for biomarker assessments in support of clinical drug development : Bioanalysis of circulating concentrations of soluble receptor activator of nuclear factor KB ligand

Journal of pharmaceutical and biomedical analysis, 2008, Vol.48 (5), p.1282-1289

2008

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Technical aspects of inductively coupled plasma bioanalysis techniques

Bioanalysis, 2013-08, Vol.5 (15), p.1831-1841

2013

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Workshop on bioanalytical methods validation for macromolecules: summary report

Pharmaceutical research, 2001-09, Vol.18 (9), p.1373-1383

2001

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Disposition of digoxin immune fab in patients with kidney failure

Clinical pharmacology and therapeutics, 1993-10, Vol.54 (4), p.388-394

1993

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Immunofluorometric assay for lamotrigine (lamictal) in human plasma

Therapeutic drug monitoring, 1991-09, Vol.13 (5), p.433-442

1991

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Ligand Binding Assays in Drug Development

The Immunoassay Handbook: Theory and applications of ligand binding, ELISA and related techniques, 2013, p.647-657

2013

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Influence of digoxin immune Fab therapy and renal dysfunction on the disposition of total and free digoxin

Annals of internal medicine, 1993-08, Vol.119 (4), p.273

1993

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Treatment of digoxin intoxication in a renal failure patient with digoxin-specific antibody fragments and plasmapheresis

American journal of nephrology, 1990, Vol.10 (6), p.518

1990

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Clinical and pharmacokinetic profiles of digoxin immune Fab in four patients with renal impairment

DICP (Cincinnati, Ohio), 1991-12, Vol.25 (12), p.1315

1991

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Chapter 8.2 - Ligand Binding Assays in Drug Development

The Immunoassay Handbook, 2013, p.647-657

Fourth Edition, 2013

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Dietary vitamin A enhances sensitivity of the local lymph node assay

Toxicology (Amsterdam), 1995-02, Vol.96 (2), p.157-163

1995

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Pre-existing anti–polyethylene glycol antibody linked to first-exposure allergic reactions to pegnivacogin, a PEGylated RNA aptamer

Pre-existing anti-PEG antibodies are associated with severe immediate allergic reactions to pegnivacogin, a PEGylated aptamer

Foreword to J Burrows’ Articles

Application of commercial research-grade biomarker assays in drug development: is it time to create 'pharmaceutical-grade' kits?

Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift

Incurred sample reanalysis: failures in macromolecule analysis--insight into possible causes

Calibration Curves in Quantitative Ligand Binding Assays: Recommendations and Best Practices for Preparation, Design, and Editing of Calibration Curves

Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays

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

Insights in the application of research-grade diagnostic kits for biomarker assessments in support of clinical drug development: Bioanalysis of circulating concentrations of soluble receptor activator of nuclear factor κB ligand

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

Understanding and mitigating impact of immunogenicity on pharmacokinetic assays

A Phase I and Pharmacokinetic Study of 1843U89, a Noncompetitive Inhibitor of Thymidylate Synthase, in Patients with Advanced Solid Malignancies

Insights in the application of research-grade diagnostic kits for biomarker assessments in support of clinical drug development: bioanalysis of circulating concentrations of soluble receptor activator of nuclear factor kappaB ligand

Insights in the application of research-grade diagnostic kits for biomarker assessments in support of clinical drug development : Bioanalysis of circulating concentrations of soluble receptor activator of nuclear factor KB ligand

Technical aspects of inductively coupled plasma bioanalysis techniques

Workshop on bioanalytical methods validation for macromolecules: summary report

Disposition of digoxin immune fab in patients with kidney failure

Immunofluorometric assay for lamotrigine (lamictal) in human plasma

Ligand Binding Assays in Drug Development

Influence of digoxin immune Fab therapy and renal dysfunction on the disposition of total and free digoxin

Treatment of digoxin intoxication in a renal failure patient with digoxin-specific antibody fragments and plasmapheresis

Clinical and pharmacokinetic profiles of digoxin immune Fab in four patients with renal impairment

Chapter 8.2 - Ligand Binding Assays in Drug Development

Dietary vitamin A enhances sensitivity of the local lymph node assay

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