| 摘要: |
| 基于国内、外文献并结合作者的临床科研实践,从药物临床试验的统计分析、项目总结、成果发布等,讨论其主要的原则与技术要点,为中药新药临床试验的总结和临床研究成果的发表提供借鉴。 |
| 关键词: 中药新药 临床试验 总结与报告 |
| DOI：10.11656/j.issn.1672-1519.2013.09.03 |
| 分类号: |
| 基金项目:科技部国家“十二五”重大新药创制资助项目(2011ZX09302-006-03) |
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| Conclusion and report of results in new drug clinical trials of TCM |
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ZHONG Cheng-liang1,2, JIA Jing-Yun1, YAN Yan1, NI Tian-Qing1, WANG Hui1, HU Si-Yuan1
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1.GCP Center, The First Affiliated Hospital of Tianjin University of TCM, Tianjin 300193, China;2.Post-Doctoral Program, China Academy of Chinese Medical Sciences, Beijing 100700, China
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| Abstract: |
| On the basis of the published paper in the world and long-term clinical and scientific practice of the author, the essential principle and key point of technology etc. in statistical analysis, item summary, result publishing in the clinical trial of new medicine of TCM have been discussed in this article. It also has provided some references for publishing the report. |
| Key words: TCM new drugs clinical trail conclusion and report |
