| 摘要: |
| 从中药新药研发的实践角度出发，围绕《基于人用经验的中药复方制剂新药临床研发指导原则》的核心内容，结合相关的政策法规、指导原则，重点分析和讨论人用经验的内涵、基于人用经验中药新药的研发计划，并对人用经验其他可能应用情形提出建议与思考，以期为采用人用经验进行中药新药研发的业内同仁提供参考。 |
| 关键词: 人用经验 中药复方制剂 中药新药 指导原则 |
| DOI：10.11656/j.issn.1672-1519.2022.11.08 |
| 分类号:R285.6 |
| 基金项目: |
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| Reflections on the application of The Guidelines for Clinical Development of New Traditional Chinese Medicine Compounded Formulations Based on Human Use Experience |
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GUO Shengxuan1,2, HU Siyuan1,2
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1.Clinical Trials Centre, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China;2.National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China
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| Abstract: |
| This paper focuses on the core contents of The Guidelines for Clinical Development of New Traditional Chinese Medicine Compounded Formulations Based on Human Use Experience from the practical perspective of traditional Chinese medicine new drug development,and analyzes and discusses the connotation of human experience,the development plan of new Chinese medicine drugs based on human experience,and makes suggestions and reflections on other possible applications of human experience,in order to provide reference for colleagues in the industry who adopt human experience for Chinese medicine new drug development. |
| Key words: human use experience traditional Chinese medicine compounded formulations new Chinese medicine guideline |
