1. Department of Clinical Pharmacology Research Lab, The First Affiliated Hospital of Soochow University, Suzhou 215006, China; 2. College of Pharmaceutical Sciences, Soochow University, Suzhou 215100, China
Abstract��Monoclonal antibody (mAb) drugs currently are an important field in drug development and playing a wide role in the treatment of autoimmune diseases and tumor. However, interindividual variability of therapeutic response and loss of response during treatment become serious problems in clinic, and the underlying mechanisms are believed to be closely related to drug exposure in patients and immunogenicity. Therapeutic drug monitoring (TDM) of mAb drugs has the potential to guide more effective dosing in individual patients and it has been proved to be helpful when making treatment decisions particularly for tumor necrosis factor inhibitors. This review is to summarize the pharmacokinetic profiles and exposure-response relationship of mAb drugs, so as to provide theoretical basis and research direction for the application of TDM in mAb drugs.
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