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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 |
| Hits 474 Download times 346 Received:July 12, 2022 |
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| DOI
10.11656/j.issn.1672-1519.2022.11.08 |
| Key Words
human use experience;traditional Chinese medicine compounded formulations;new Chinese medicine;guideline |
| Author Name | Affiliation | E-mail | | GUO Shengxuan | Clinical Trials Centre, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China | | | HU Siyuan | Clinical Trials Centre, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China | husiyuan1963@sina.com |
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| Abstract
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| 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. |
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