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Key elements of bioanalytical method validation for macromolecules

The AAPS journal, 2007-05, Vol.9 (2), p.E156-E163

2007

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

The AAPS journal, 2009-06, Vol.11 (2), p.238-241

2009

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Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules

Pharmaceutical research, 2003-11, Vol.20 (11), p.1885-1900

2003

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Translating Molecular Biomarkers into Clinical Assays: Techniques and Applications

1, 2016

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ISR: background, evolution and implementation, with specific consideration for ligand-binding assays

Bioanalysis, 2014-02, Vol.6 (3), p.393-402

2014

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Validation of cell-based assays in the GLP setting: a practical guide

1, 2008

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Development and validation of ELISA for Herceptin detection in human serum

Journal of immunological methods, 2004-12, Vol.295 (1), p.169-182

2004

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Incurred sample reanalysis: it is just a matter of good scientific practice

Bioanalysis, 2011-05, Vol.3 (9), p.931-932

Kelley, Marian

2011

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Bioanalytical Approaches to Quantify “Total” and “Free” Therapeutic Antibodies and Their Targets: Technical Challenges and PK/PD Applications Over the Course of Drug Development

The AAPS journal, 2011-03, Vol.13 (1), p.99-110

2011

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One size does not fit all

Bioanalysis, 2011-03, Vol.3 (5), p.473-475

Kelley, Marian

2011

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Theoretical Considerations and Practical Approaches to Address the Effect of Anti-drug Antibody (ADA) on Quantification of Biotherapeutics in Circulation

The AAPS journal, 2013-07, Vol.15 (3), p.646-658

2013

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Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics

Journal of immunological methods, 2007-04, Vol.321 (1), p.1-18

2007

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Large Molecule Specific Assay Operation: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

The AAPS journal, 2014-01, Vol.16 (1), p.83-88

2014

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The Impact of Computer-Assisted Interventions on Academic Growth in Reading Comprehension

Kelley, Marian I'Lecia

2019

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2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS

Bioanalysis, 2013-12, Vol.5 (23), p.2903-2918

2013

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Large Molecule Run Acceptance: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

The AAPS journal, 2014-03, Vol.16 (2), p.221-225

2014

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Recommendations from the Global Bioanalysis Consortium Team A8: Documentation

The AAPS journal, 2014-03, Vol.16 (2), p.240-245

2014

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Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated Environment

The AAPS journal, 2015-07, Vol.17 (4), p.1019-1024

2015

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The pharmacokinetics of erythropoietin in the cerebrospinal fluid after intravenous administration of recombinant human erythropoietin

European journal of clinical pharmacology, 2005-05, Vol.61 (3), p.189-195

2005

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Quality assessment of bioanalytical quantification of monoclonal antibody drugs

Therapeutic delivery, 2011-03, Vol.2 (3), p.383-396

2011

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In Situ Hybridization in Clinical Biomarker Development

Translating Molecular Biomarkers into Clinical Assays, 2016, Vol.21, p.201-210

2016

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Biomarker Discovery

Translating Molecular Biomarkers into Clinical Assays, 2016, Vol.21, p.27-35

2016

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Biomarkers in Drug Discovery and Development: Pre-analytical and Analytical Considerations

Translating Molecular Biomarkers into Clinical Assays, 2016, Vol.21, p.17-25

2016

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Current Flow Cytometry Methods for the Clinical Development of Immunomodulatory Biologics

Translating Molecular Biomarkers into Clinical Assays, 2016, Vol.21, p.141-151

2016

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Key elements of bioanalytical method validation for macromolecules

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

Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules

Translating Molecular Biomarkers into Clinical Assays: Techniques and Applications

ISR: background, evolution and implementation, with specific consideration for ligand-binding assays

Validation of cell-based assays in the GLP setting: a practical guide

Development and validation of ELISA for Herceptin detection in human serum

Incurred sample reanalysis: it is just a matter of good scientific practice

Bioanalytical Approaches to Quantify “Total” and “Free” Therapeutic Antibodies and Their Targets: Technical Challenges and PK/PD Applications Over the Course of Drug Development

One size does not fit all

Theoretical Considerations and Practical Approaches to Address the Effect of Anti-drug Antibody (ADA) on Quantification of Biotherapeutics in Circulation

Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics

Large Molecule Specific Assay Operation: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

The Impact of Computer-Assisted Interventions on Academic Growth in Reading Comprehension

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

2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS

Large Molecule Run Acceptance: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

Recommendations from the Global Bioanalysis Consortium Team A8: Documentation

Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated Environment

The pharmacokinetics of erythropoietin in the cerebrospinal fluid after intravenous administration of recombinant human erythropoietin

Quality assessment of bioanalytical quantification of monoclonal antibody drugs

In Situ Hybridization in Clinical Biomarker Development

Biomarker Discovery

Biomarkers in Drug Discovery and Development: Pre-analytical and Analytical Considerations

Current Flow Cytometry Methods for the Clinical Development of Immunomodulatory Biologics

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