中药新药一般毒理试验及评价

Toxicity test and assessment to new drug in traditional medicine

根据多年研究实践,针对新药一般毒理试验及临床前安全性评价进行探讨,提出新药一般毒理试验需在12个环节中予以重视和加强管理。

In this paper, author sums up his experience on the pre-clinical toxicity studies included acute or chronic toxicity tests on new drug and emphasizes that there are 12 key issues should be paid attention to and the GLP should be conformed strictly for toxicity studies.