Model-informed drug development (MIDD) is a major shift of new mode of drug development based on the establishment of PK-PD model using blood concentration- (i.e., exposure, PK) and efficacy/safety (i.e., response, PD)-corresponding data, in order to analyze exposure-response relationship, replace dose-response relationship that is difficult to obtain, and establish the chain of evidence on drug safety and efficacy. The above model can integrate data from in vitro and in vivo, animals and human beings, adults and children, literature and trials, original and new dosage forms, domestic and foreign trials, and other sources to solve a wide range of key clinical problems. It is particularly important to transform the exploration paradigm of new drug development into a model verification mode. Therefore, MIDD is not only related to the change of technical means, but also the integration of multidisciplinary research, as well as a change of research and development strategy and scientific regulatory. It greatly improves the efficiency and success rate of new drug research and development. Based on the summary of MIDD success cases, this paper tries to clarify the basic principle, concept and method, implementation path, and takes anti-psoriasis monoantibody as an example to establish a complete MIDD working mode.

pharmcometrics  /  modeling & simulation  /  exposure-response relationship  /  dose-response relationship  /  model-informed drug development