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Points to Consider Document: Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices, June 2019
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Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment
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Recommendations for Preparation, Design, and Editing of Calibration Curves
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Meat allergy associated with galactosyl-α-(1,3)-galactose (α-Gal)-Closing diagnostic gaps by anti-α-Gal IgE immune profiling
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Managing unwanted immunogenicity of therapeutic proteins
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2016 White Paper, Recent Issues in Bioanalysis Part 3 – LBA, Biomarkers, and Immunogenicity
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Humoral Immune Response to AAV
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Establishment of the first WHO Erythropoietin antibody reference panel: Report of an international collaborative study
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Analysis of the new IgG4 monoclonal antibody GNbAC1 to treat multiple sclerosis: A Phase 1 study
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B cell epitopes on infliximab identified by oligopeptide microarray with unprocessed patient sera
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The quintessence of immunogenicity reporting for biotherapeutics
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Preclinical and early clinical development of GNbAC1, a humanized IgG4 monoclonal antibody targeting endogenous retroviral MSRV-Env protein
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2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity)
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2014 White Paper on Recent Issues in Bioanalysis: A Full Immersion in Bioanalysis (Part 3 – LBA and Immunogenicity)
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7th GCC Insights: Incurred samples use, solution stability, and more
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Case Studies: Challenges of Supporting Comparability Work for Biosimilars
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7th GCC Insights: incurred samples use; fitfor- Purpose Validation, Solution Stability, Electronic Laboratory Notebook and Hyperlipidemic Matrix Testing
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Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments
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Recommendations on incurred sample stability (ISS) by GCC
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Potential induction of anti-PEG antibodies – PEGylated therapeutics
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Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides-Harmonized Terminology and Tactical Recommendations
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8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation
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Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)
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Recent Issues in Bioanalysis and Alignment of Multiple Guidelines
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Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations
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Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years’ experience of the European Union regulatory pathway
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Application of miniaturized immunoassays to discovery pharmacokinetic bioanalysis
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2013 White Paper on recent issues in bioanalysis: ‘hybrid’–the best of LBA and LCMS
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Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumab
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Immune responses to AAV vectors: overcoming barriers to successful gene therapy
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Oncogenic Pim-3 Kinase Can Counteract Chemoresistance in Pancreatic Cancer
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Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development
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Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis
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In vitro and in vivo studies of IgG-derived Treg epitopes (Tregitopes)
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Biosimilars: what clinicians should know
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Setting the stage for biosimilar monoclonal antibodies
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6th GCC Focus on LBA: Critical Reagents, Positive Controls and Reference Standards; Specificity for Endogenous Compounds; Biomarkers; Biosimilars
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Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars
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Recommendations on biomarker bioanalytical method validation by GCC
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Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)
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Immunogenicity assays and comparability studies in biosimilar drugs
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2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines
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Recommendations on Bioanalytical Method Stability Implications of Co-Administered and Co-Formulated Drugs by Global CRO Council for Bioanalysis (GCC)
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6th GCC – “Focus on Ligand-Binding Assays”
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Recommendations on the Interpretation of the New European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)
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Ligand-Binding Assays in the 21st Century Laboratory: Recommendations for an Automated Data Interchange Process
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Ligand Binding Assays: Recommendations for Characterization and Supply of Critical Reagents
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Ligand Binding Assays in the 21st Century Laboratory: Automation
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Ligand Binding Assays in the 21st Century Laboratory: Platforms
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Recommendations on the Interpretation of the new EMA Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis
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Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development
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