新药研发中群体药动学/药效学研究的一般考虑

General considerations of population pharmacokinetic/pharmacodynamic study in new drug development

群体药动学/药效学研究以及基于此之上的量效关系研究已成为新药研发与监管的工具与重要组成部分。将其有机地嵌入新药研发和评审过程中,将能够使研发和评审更为高效,并回答一些传统药动学/药效学无法回答的问题。作为专家共识,本文对群体药动学/药效学研究在新药研发与评审中的应用、试验设计、模型分析方法、分析结果的质量控制与研究报告内容进行了论述。作者们期望本文能为群体药动学/药效学研究在我国新药研发中的应用提供积极有益的参考。

Population pharmacokinetic/pharmacodynamic (PopPK/PD) study and so derived exposure-response study are key components in new drug development and regulatory decision making. Integrating such studies into new drug development will facilitate new drug development and regulatory decision-making processes. As an expert consensus, this document provides the areas of applications, clinical trial designs, modeling analysis methods, quality control concerns and study reporting formats of PopPK/PD studies in new drug development/regulatory submissions. The authors expect this document can be a valuable reference to those scientists and regulatory reviewer who wish to adapt PopPK/PD studies into new drug development and drug approval processes in China.