中药新药非临床安全性研究中的常见问题

Problems in nonclinical safety research of new traditional Chinese medicines

非临床安全性研究在药物研发中所占的地位非常重要。近年来中药新药非临床安全性研究的水平逐渐提高,但审评过程中仍存在一些问题。本文通过分析探讨中药非临床安全性评价现状以及非临床安全性试验的设计、质量控制、结果分析等,发现一些常见的问题,并针对所发现的问题提出一些建议。

Nonclinical safety research is very important for drug development. Though the scientific level of nonclinical safety research of TCM is higher and higher, we can still find some problems during the review process. By analyzing the present situation of nonclinical safety research of new TCM, the quality control, research project, and analysis of the test results, the author try to sum up the common problems and give some advices.