已知活性成分开发局部给药局部起效药物临床试验的考虑  

The Correlation Factor Analysis of Clinical Trial for Locally Applied Locally Acting Drug with A Known Active Component

作　　者：符世平[1] 谢松梅[2] 

机构地区：[1]洛阳市中心医院,洛阳471009 [2]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国皮肤性病学杂志》2008年第12期765-766,共2页The Chinese Journal of Dermatovenereology

摘　　要：目的结合局部给药局部起效药物的特点,初步探讨已知活性成分开发该类药物时进行临床试验设计和评价的相关因素。方法采用文献相关分析、总结方法。结果该类药物应参考已知活性成分的已有研发情况,选择进行相应的临床试验,试验应关注局部药代、局部药效、局部耐受性等研究,并通过适当的临床试验和/或桥接试验证实其与已上市的相同活性成分药物的等效性。结论合理选择开展临床试验是支持该类药物安全有效性评价的基础。Objective To investigate the correlation factors of clinical trial design and evaluation for locally applied locally acting drug containing known active component according to the characteristics of the locally acting drug. Methods Literature correlation analysis and summary methods. Results Adequate clinical trials should be carried out according to the research foundation of known active component. The local pharmacokinetic, local pharmacodynamic and local tolerance studies should be considered. Then adequate clinical trial and/or bridging trial would demonstrate therapeutic equivalence with known drug. Conclusion The safety and efficacy evaluation of this kind of drugs based on the reasonable choice of clinical trials.

关 键 词：活性成分 局部给药 局部起效 药物 临床试验 

分 类 号：R969.3[医药卫生—药理学]