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European Bioanalysis Forum recommendation on singlicate analysis for ligand binding assays: time for a new mindset

Bioanalysis, 2020-03, Vol.12 (5), p.273-284

2020

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Analytical assay platforms for soluble target engagement biomarkers: old favorites and emerging technologies

Bioanalysis, 2013-12, Vol.5 (23), p.2919-2931

2013

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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, p.1-8

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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European Bioanalysis Forum feedback on draft ICH M10 guideline on bioanalytical method validation during the Step 2b public consultation period

Bioanalysis, 2020-03, Vol.12 (6s), p.1

2020

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Toward decision-based acceptance criteria for Bioanalytical Method Validation: a proposal for discussion from the European Bioanalysis Forum

Bioanalysis, 2018-08, Vol.10 (16), p.1255-1259

2018

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European Bioanalysis Forum feedback on draft ICH M10 guideline on bioanalytical method validation during the Step 2b public consultation period

Bioanalysis, 2020-03, Vol.12 (6s), p.1-11

2020

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Conference Report from the European Bioanalysis Forum Workshop: toward harmonized implementation of the ICH M10 guideline

Bioanalysis, 2022-11, Vol.14 (22), p.1407-1411

2022

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

Bioanalysis, 2024-08, p.1-7

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 and discussion points on immunogenicity, biomarkers, automation/technology and protein–MS from the 2021 European Bioanalysis Forum Focus Workshops

Bioanalysis, 2021-10, Vol.13 (19), p.1459-1465

2021

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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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EBF recommendation on practical management of critical reagents for PK ligand-binding assays

Bioanalysis, 2018-10, Vol.10 (19), p.1557-1565

2018

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EBF recommendation on practical management of critical reagents for antidrug antibody ligand-binding assays

Bioanalysis, 2019-10, Vol.11 (19), p.1787-1798

2019

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Addressing the challenges of biomarker calibration standards in ligand-binding assays: a European Bioanalysis Forum perspective

Bioanalysis, 2017-10, Vol.9 (19), p.1493-1508

2017

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Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles

Bioanalysis, 2018-02, Vol.10 (4), p.197-204

2018

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European Bioanalysis Forum recommendation on singlicate analysis for ligand binding assays: time for a new mindset

Analytical assay platforms for soluble target engagement biomarkers: old favorites and emerging technologies

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

European Bioanalysis Forum feedback on draft ICH M10 guideline on bioanalytical method validation during the Step 2b public consultation period

Toward decision-based acceptance criteria for Bioanalytical Method Validation: a proposal for discussion from the European Bioanalysis Forum

European Bioanalysis Forum feedback on draft ICH M10 guideline on bioanalytical method validation during the Step 2b public consultation period

Conference Report from the European Bioanalysis Forum Workshop: toward harmonized implementation of the ICH M10 guideline

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

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

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

Recommendations and discussion points on immunogenicity, biomarkers, automation/technology and protein–MS from the 2021 European Bioanalysis Forum Focus Workshops

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

EBF recommendation on practical management of critical reagents for PK ligand-binding assays

EBF recommendation on practical management of critical reagents for antidrug antibody ligand-binding assays

Addressing the challenges of biomarker calibration standards in ligand-binding assays: a European Bioanalysis Forum perspective

Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles

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