中药复方制剂临床试验申请的非临床研究关注要点

Non-clinical research concerns for clinical trial applications of compound preparations of traditional Chinese medicine

中药复方制剂新药是最能体现中医药理论特色和人用经验的中药创新药。近年来,在中药创新药临床试验(investigational new drug,IND)申请中,中药复方制剂占大部分。非临床研究对于中药创新药IND申请的获益风险评估具有重要作用,中药复方制剂IND申请之前需根据品种的特点和临床定位,完成必要的药效学研究和毒理学研究。根据非临床有效性和安全性结果,结合品种的特点和人用经验,综合评估品种初步的获益-风险和潜在的临床价值。结合案例分析,探讨中药复方制剂IND申请中的非临床研究关注点,以及通过获益-风险评估对品种能否进入临床试验进行的决策考虑,以期为中药研发和注册申报提供参考。

The new compound preparations of traditional Chinese medicine(TCM)are innovative TCMs which can best reflect the theoretical characteristics of TCM and human use experience.In recent years,the new compound preparations of TCM account for the majority of investigational new drug(IND)applications for innovative TCMs.Nonclinical studies play an important roles in the benefit-risk assessment of IND applications for innovative TCMs.Therefore,according to specific characteristics and clinical orientation of product,necessary pharmacodynamic and toxicological studies should be completed before IND application.Based on nonclinical efficacy and safety results,combined with the characteristics and human experience,the preliminary benefit-risk and potential clinical value of the product were comprehensively evaluated.Combining with the case analysis,the non-clinical study concerns in the IND application of the new compound preparations of TCM were discussed,as well as decision-making consideration on whether the product can enter clinical trials through benefit-risk assessment,so as to provide a reference for the research and development and registration of TCMs.