| 韦晓瑜,吴娜,龙继红.试析民族药品种上市后的再研究[J].中国药事,2017,(1):27-31 |
| 试析民族药品种上市后的再研究 |
| Tentative Analysis on the Supplementary Research for the On-sale Ethnic Medicinal Products |
| 投稿时间：2016-08-18 |
| DOI：10.16153/j.1002-7777.2017.01.006 |
| 中文关键词: 民族药品种 临床研究 药学研究 药理毒理研究 民族医药理论 上市后再研究 |
| 英文关键词: ethnic medicinal products clinical study pharmaceutical study pharmacological and toxicological study ethnic medicine theory supplementary research on the products being on-sale |
| 基金项目: |
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| 摘要点击次数: 827 |
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| 中文摘要: |
| 目的：探讨已上市民族药品种的再研究路径。方法：对已上市民族药品种的临床、药学及药理毒理研究情况进行分析。结果与结论：民族药品种的上市前研究因科学发展水平、监管历史、民族政策等原因存在诸多先天不足，有必要进行上市后再研究；研究应先理清存在的关键性问题，再结合品种实际特点，在民族医药理论的指导下分阶段开展。 |
| 英文摘要: |
| Objective: To discuss the supplementary research modes for the on-sale ethnic medicinal products. Methods: The status about the clinical study, pharmaceutical study, and pharmacological as well as toxicological study of on-sale ethnic medicinal products was analyzed. Results and Conclusion: Many inherent deficiencies exist in the research on pre-sale ethnic medicinal products due to the underdevelopment of science, regulatory history, national policies and the like, thus it is necessary to conduct supplementary research on the products being on-sale. It is proposed herein that we identify the key problems firstly, and then carry out the research in stages with the guidance of the ethnic medicine theory in conjunction with the actual characteristics of the products. |
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