Advances in pharmacokinetic and pharmacodynamic modeling of monoclonal antibody

The successes of therapeutic monoclonal antibodies(mAbs)in clinical practice has drawn more attention to mAbs development. Compared to chemical drugs with small molecules, mAbs have larger molecular weight; besides, they show much higher selectivity and specificity. As a result, new pharmacokinetic(PK)and pharmacokinetic/pharmacodynamic(PK/PD)models have been proposed to guide mAbs development. This article summarizes the unique PK characteristics of mAbs and introduces the models used in PK investigation of mAbs, such as target-mediated drug disposition(TMDD)model and physiologically based pharmacokinetic(PBPK)model. In addition, four different categories of PK/PD models for mAbs in immuno-toxicotherapy, target-cell elimination, alteration of cellular function and drug targeting are also reviewed in the present article.