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| Practice and thinking of regulatory science in clinical research for the dominant diseases of Chinese ophthalmology |
| Hits 142 Download times 53 Received:May 06, 2024 |
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| DOI
10.11656/j.issn.1672-1519.2024.09.01 |
| Key Words
traditional Chinese medicine;regulatory science;ophthalmology;dominant diseases |
| Author Name | Affiliation | E-mail | | AN Na | Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China | | | KE Yushi | Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China | | | ZHAO Zhihong | Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China | | | MA Xiujing | Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China | maxj@cde.org.cn |
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| Abstract
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| Traditional Chinese ophthalmology is an important branch of traditional Chinese medicine (TCM),the development of TCM new drugs related to the dominant diseases of Chinese ophthalmology has attracted more and more attention. Conducting clinical research in the dominant diseases of Chinese ophthalmology is benefit for leveraging the value of TCM theory and clinical practice,exploring the advantages and characteristics of patient benefits and traditional Chinese medicine treatment,and improving eye health. In regulatory science,the development of new tools,new standards and new methods with the characteristics of TCM will reduce the uncertainty in regulatory decision-making and meet the accessibility of medicine. Combined with the drug review,this paper focuses on the effectiveness evaluation of TCM supervision and control of dominant diseases in Chinese ophthalmology. It can serve clinical research and evaluation,accelerate the transformation and application of TCM new drugs in ophthalmology,and promote the inheritance,innovation and high-quality development of TCM. |
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