Model-Informed Approach Supporting Innovative Drug Evaluation and Regulatory Decision-Making in China
Model-informed drug development(MIDD)has been widely used in different stages of innovative drug development.The Guidance for Model-Informed Drug Development was issued by the Center for Drug Evaluation of National Medical Product Administration in December 2020.It not only encourages applicants to rationally use modeling and simulation methods throughout the whole lifecycle of drug development,but also prompts reviewers to make decisions supported by MIDD.This article mainly presents cases of model-informed approach supporting drug development and regulatory evaluation in areas such as dose selection for clinical trials of innovative drugs,risk-benefit assessment,pediatric extrapolation,dose adjustment for special populations,and assessment of drug-drug interactions.It aims to further promote the application of modeling and simulation in innovative drug development and enhance the efficiency of drug review and regulatory decision-making.
model-informed drug developmentdose optimizationrisk-benefitpediatric extrapolationdrug-drug interaction
万方数据
维普
