Development and validation of LC-MS/MS method for the quantization of therapeutic monoclonal antibod

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  Discovery and development of therapeutic protein dugs have been a major focus in the pharmaceutical industry in recent years.Understanding pharmacokinetic/pharmacodynamic relationships of these drugs is critical in preclinical and clinical studies.Historically, immunological techniques such as enzyme-linked immunosorbent assay (ELISA) have been used to quantify protein drug.However, these assays have major drawbacks, such as lengthy development time, difficulties in getting suitable antigen;Nowadays, liquid chromatography coupled with mass spectrometry (LC-MS/MS) has been increasingly used for quantification of therapeutic proteins.
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