摘要：Target-mediated drug disposition (TMDD)model is one of the main modeling theories for studying nonlinear pharmacokinetics (PK)ofmonoclonal ***,there are too many parameters in full TMDD model to be estimated based on limited clinical data,leading to instability of the final *** the present study,we analyzed the predictive ability and applicability of a simplified quasi-steady state (QSS)model with the assumption that the total target concentration was a constant parameter during treatment with monoelonal antibody in clinical data *** on the parameters of a published TMDD model of denosumab,simulations were performed at population and individual ***,a simplified TMDD model,QSS model, was used to examine the effects of hypotheses,in which the total receptor concentration was constant or variable on model fit and stability of parameter *** simulations at the population level and model fit results of simulated individual data showed that at the therapeutic doses,the total receptor concentration had little influence on changes in drug concentration,and the model with constant total receptor concentration had the same predictive *** validated hypothesis could be applied to clinical trial design and selection of the optimal PK model in the development of monoclonal antibodies.