中药新药药效学试验设计的关注要点与思考

药效学研究是中药新药研发中的重要环节，通过前期的药理毒理试验来考察成药性，为后期临床试验提供支持性数据，可减少后期研发风险。近年来中药药效学研究不断发展和进步，但是仍存在一些问题，影响了药效学研究在中药新药研发中作用的发挥。科学合理的设计是实现药效学试验价值与目标的基础。该文总结了审评工作中中药药效学试验设计方面存在的常见缺陷，包括试验项目、检测指标、给药剂量、给药时间、对照、检测时间点等方面的缺陷。在此基础上，提出了中药药效学试验设计的总体思路、关注要点以及具体要求，并提出一些思考。

Concern points and considerations for pharmacodynamic study design of new traditional Chinese medicines

Pharmacodynamic(PD) studies play an important role in research and development of new traditonal Chinese medicines(TCMs). Phamacologic and toxicologic studies that aim to research druggability can provide supporting data for the clinical trials and reduce the risk of clinical trials. In recent years, PD studies in TCMs are developing and progressing, but there are still some problems affecting the value of PD studies in the development of new TCMs. The value of PD studies depends on scientific and rational study design. This article summaries some defects in PD study design of new TCMs that are common in the application data, including defects in study type, testing targets, dosing, duration of administration, control group, testing time.This article also discusses some points of concern and specific requirements for PD study design of new TCMs.