Development and validation of a multiplexed drug level assay in support of combination biologics therapy clinical studies.

Huaping Tang, Ketal Shah,Thomas Steinmetz,Anson Abraham, Hans Jensen, Andrew Bouton, Kasia Marullo,Shuangping Shi

Journal of Pharmaceutical and Biomedical Analysis（2019）

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摘要

•A multiplex assay was developed to measure two monoclonal antibodies in one sample.•The assay was fully validated with no significant cross-reactivity.•The assay is used in supporting combination therapy in the clinic.

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关键词

MSD® U-PLEXTM,Multiplex,Ligand binding assay,Drug level assay,PK assay,Combination biologics therapy

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