创新药群体药代动力学研究申报资料的探讨

群体药代动力学(PopPK)是对药物浓度个体间变异进行定量分析的一种研究方法,现已被广泛应用于新药从非临床到临床研究的各个阶段。随着PopPK研究技术的快速发展,越来越多的新药研发企业热衷于采用模型化和仿真的方法对药物的体内过程及其影响因素进行综合分析。我国药品监管机构发布的技术要求中,已有多个指导原则提出了开展PopPK研究的建议,但尚未对PopPK研究的注册申报资料提出明确要求。本文结合笔者既往审评经验,以及国内、外相关技术指导原则的要求,对创新药PopPK研究及其申报资料的整理进行了初步探讨,供新药开发企业和研究人员讨论或参考。

Discussion on the format and content of new drug population pharmacokinetic study report

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.