关键词: 创新药, 群体药代动力学, 模型化和仿真, 协变量分析, 研究报告

Abstract: Population pharmacokinetics (PopPK) is an analytical method that can quantify the variability of drug concentration among individuals. It is widely used in various stages of new drug researches from non-clinic to clinic. With the rapid development of PopPK, more and more sponsors are keen to comprehensively analyze the in vivo processes of new drugs as well as its influencing factors using modeling and simulation methods. Several guidelines have been issued to recommend the use of PopPK in China. However, no explicit requirement of PopPK study report has been issued for regulatory application. This article conducts a preliminary discussion on new drug PopPK study and its reporting format and content, with reference to the requirements in relevant guidelines as well as previous review experiences, for the discussion or reference of industries and researchers.

Key words: new drug, population pharmacokinetics, modeling and simulation, covariate analysis, study report