Application of target-mediated drug disposition (TMDD) models in the development of monoclonal antibody

doi:10.12092/j.issn.1009-2501.2018.03.001

Abstract

Abstract:

In recent years, monoclonal antibodies have become the area of interest in industry. Unlike small molecules, monoclonal antibodies exhibit unique structural and physiological properties, alongside with differences in absorption, distribution, metabolism and excretion. These unique properties of monoclonal antibodies［e.g. target-mediated drug disposition (TMDD), nonlinear pharmacokinetics, time-dependence and long half-life］ pose several challenges in drug development. Appropriate application of modeling and simulation techniques can help researchers with data mining, predicting clinical trial outcomes, guiding clinical trial designs and optimizing dosing schemes. Among these, the application of the TMDD model in the monoclonal antibody development is growing. In this review, a brief introduction on the pharmacokinetic properties of monoclonal antibodies is provided, followed by a discussion on the feasibility and necessity of applying the TMDD model to monoclonal antibody drug development. The aim of current work is to provide a reference for researchers to scientifically and efficiently conduct studies on the monoclonal antibodies.

Key words: monoclonal antibodies, pharmacokinetics, target-mediated drug disposition

CLC Number:

R969

JI Shuangmin, ZHU Xiao. Application of target-mediated drug disposition (TMDD) models in the development of monoclonal antibody[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, doi: 10.12092/j.issn.1009-2501.2018.03.001.

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