摘要Model-informed drug develop-ment(MIDD)is the application of a various math-ematical,statistical,and biological models to facilitate drug development,decision making and regulatory review.As a quantitative tool,MIDD approaches allow an integration of information obtained from non-clinical studies and clinical trials in a drug development program.General understandings of the underlying biology,patho-physiology,and pharmacology can also be incor-porated into the model.MIDD is centered on knowledge and inferences generated from inte-grated models of the physicochemical character-istics of a molecule,its disposition in the body,and its mechanism of action,and how the drug might affect a disease from both an efficacy and a safety perspective.MIDD approaches have the potential to significantly streamline drug develop-ment,by improving clinical trial efficiency,opti-mizing dose and regimen and waive unneces-sary clinical studies.This presentation will use cases studies to demonstrate how to apply MIDD in early phase of clinical trials.