Demonstrating biosimilar and originator antidrug antibody binding comparability in antidrug antibody assays: a practical approach.

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Technologies and strategies for bioanalysis of biopharmaceuticals.Welcome to volume 10 of Bioanalysis.

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Demonstrating biosimilar and originator antidrug antibody binding comparability in antidrug antibody assays: a practical approach.

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2017 nî lūn-bûn

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2017年の論文

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Demonstrating biosimilar and o ...... assays: a practical approach.

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Demonstrating biosimilar and o ...... assays: a practical approach.

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Demonstrating biosimilar and o ...... assays: a practical approach.

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Demonstrating biosimilar and o ...... assays: a practical approach.

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Janka Ryding

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Martin Ullmann

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Michael Stahl

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P2860

Evaluation of the Cross-reactivity of Antidrug Antibodies to CT-P13 and Infliximab Reference Product (Remicade): An Analysis Using Immunoassays Tagged with Both Agents.

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

Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products.

The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects

Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development.

Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development.

Assessing immunogenicity of biosimilar therapeutic monoclonal antibodies: regulatory and bioanalytical considerations.

Comparative immunogenicity assessment: a critical consideration for biosimilar development.

Key considerations in the preclinical development of biosimilars.

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).

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1395-1406

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scholarly article

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10.4155/BIO-2017-0111

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antibody

Demonstrating biosimilar and originator antidrug antibody binding comparability in antidrug antibody assays: a practical approach.

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P2860

Demonstrating biosimilar and originator antidrug antibody binding comparability in antidrug antibody assays: a practical approach.

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