Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations.
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Understanding the Supersensitive Anti-Drug Antibody Assay: Unexpected High Anti-Drug Antibody Incidence and Its Clinical RelevanceAssessing the Immunogenicity of BiopharmaceuticalsStandardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: recommendations of the Innovative Medicines Initiative ABIRISK consortiumUnraveling the Effect of Immunogenicity on the PK/PD, Efficacy, and Safety of Therapeutic ProteinsAntidrug Antibodies: B Cell Immunity Against TherapyClinical Outcomes of Patients with Diabetes Who Exhibit Upper-Quartile Insulin Antibody Responses After Treatment with LY2963016 or Lantus® Insulin Glargine.Clinical Immunogenicity of rHuPH20, a Hyaluronidase Enabling Subcutaneous Drug Administration.Cross-reactive and pre-existing antibodies to therapeutic antibodies--Effects on treatment and immunogenicity.B cell epitopes on infliximab identified by oligopeptide microarray with unprocessed patient sera.Evaluation of immunogenicity of LY2963016 insulin glargine compared with Lantus® insulin glargine in patients with type 1 or type 2 diabetes mellitus.Pre-existing Antibody: Biotherapeutic Modality-Based Review.Evaluating and Reporting the Immunogenicity Impacts for Biological Products--a Clinical Pharmacology PerspectiveDevelopment of Immunocapture-LC/MS Assay for Simultaneous ADA Isotyping and Semiquantitation.Secukinumab, a novel anti-IL-17A antibody, shows low immunogenicity potential in human in vitro assays comparable to other marketed biotherapeutics with low clinical immunogenicity.A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy.Comparative immunogenicity assessment: a critical consideration for biosimilar development.Comparison of immunogenicity test methods used in clinical studies of infliximab and its biosimilar (CT-P13).From the bench to clinical practice: understanding the challenges and uncertainties in immunogenicity testing for biopharmaceuticals.Mouse Models for Assessing Protein Immunogenicity: Lessons and Challenges.Evaluation of the immunogenicity of the dabigatran reversal agent idarucizumab during Phase I studies.2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).Low incidence of anti-drug antibodies in patients with type 2 diabetes treated with once-weekly glucagon-like peptide-1 receptor agonist dulaglutide.The Role of Aggregates of Therapeutic Protein Products in Immunogenicity: An Evaluation by Mathematical Modeling.Immunogenicity of antibody drug conjugates: bioanalytical methods and monitoring strategy for a novel therapeutic modality.2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).The quintessence of immunogenicity reporting for biotherapeutics.Multimodality Imaging of Angiogenesis in a Rabbit Atherosclerotic Model by GEBP11 Peptide Targeted Nanoparticles.Immunogenicity of therapeutic protein products: current considerations for anti-drug antibody assay in Japan.Quartz crystal microbalance as an assay to detect anti-drug antibodies for the immunogenicity assessment of therapeutic biologics.Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results.Phase III Randomized Study of SB5, an Adalimumab Biosimilar, Versus Reference Adalimumab in Patients With Moderate-to-Severe Rheumatoid Arthritis.Clinical Pharmacology Considerations for the Development of Immune Checkpoint Inhibitors.CCL20 neutralization by a monoclonal antibody in healthy subjects selectively inhibits recruitment of CCR6+ cells in an experimental suction blister.Anti-Insulin Antibodies and Adverse Events with Biosimilar Insulin Lispro Compared with Humalog Insulin Lispro in People with Diabetes.Assay signal as an alternative to titer for assessment of magnitude of an antidrug antibody response.Immunogenicity and biomarkers: bioanalytical challenges and considerations.Assessment of human antihuman antibodies to eculizumab after long-term treatment in patients with paroxysmal nocturnal hemoglobinuria.Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects.Response to: 'Reporting of potential immunogenicity with biologic drugs: clarity and accuracy required' by Moots et al.Comparing the immunogenicity of the etanercept biosimilar SB4 with the innovator etanercept: another consideration.
P2860
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P2860
Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations.
description
2014 nî lūn-bûn
@nan
2014 թուականի Ապրիլին հրատարակուած գիտական յօդուած
@hyw
2014 թվականի ապրիլին հրատարակված գիտական հոդված
@hy
2014年の論文
@ja
2014年論文
@yue
2014年論文
@zh-hant
2014年論文
@zh-hk
2014年論文
@zh-mo
2014年論文
@zh-tw
2014年论文
@wuu
name
Assessment and reporting of th ...... and tactical recommendations.
@ast
Assessment and reporting of th ...... and tactical recommendations.
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type
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Assessment and reporting of th ...... and tactical recommendations.
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Assessment and reporting of th ...... and tactical recommendations.
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Assessment and reporting of th ...... and tactical recommendations.
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Assessment and reporting of th ...... and tactical recommendations.
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P2093
P2860
P1433
P1476
Assessment and reporting of th ...... and tactical recommendations.
@en
P2093
A Kromminga
American Association of Pharmaceutical Scientists
C K Schneider
D Verthelyi
M Subramanyam
S Kirshner
S Richards
P2860
P2888
P304
P356
10.1208/S12248-014-9599-2
P407
P577
2014-04-24T00:00:00Z
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P6179
1008471779