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近些年来,国家和业界对药物创新的整体认知水平不断提高,研发能力不断加强,新药非临床研究与评价中出现了一些新的值得关注的问题:首先在安全性研究与评价技术方面,中药、化药没有实质性差异,研究评价的基本思路和技术标准应统一,相应研究的技术指导原则应统一。其次,在非临床安全性研究的质量方面,一是支持药品注册的非临床安全性研究均应严格执行GLP,保障数据的真实性、完整性、可靠性以及可溯源性,提高药物研究质量和非临床安全性评价水平,二是应加强受试物分析,是非临床安全性研究与评价获取可靠结果的物质基础。此外,毒代与药代动力学研究、致癌性研究等也是值得关注的问题。
In recent years, the overall cognition of drug innovation by the state and the industry has been continuously improved, and the R & D capability has been continuously strengthened. Some new issues of concern to new drug nonclinical research and evaluation have emerged. First, in terms of safety research and evaluation techniques, There is no substantial difference between traditional Chinese medicine and chemical medicine. The basic ideas and technical standards for research and evaluation should be unified, and the technical guidelines for corresponding research should be unified. Second, in the aspect of the quality of non-clinical safety research, firstly, non-clinical safety research supporting drug registration should strictly enforce GLP to ensure the authenticity, integrity, reliability and traceability of data and improve the quality of drug research Non-clinical safety evaluation level, the second is to strengthen the test substance analysis, non-clinical safety research and evaluation to obtain reliable results of the material basis. In addition, toxicokinetics and pharmacokinetic studies, carcinogenicity studies are also issues of concern.