文章摘要
李金洲,马文艳,米璇,由春娜.美欧关于透皮贴剂临床研究要求的探究与思考[J].中国药事,2022,36(6):713-722
美欧关于透皮贴剂临床研究要求的探究与思考
Exploration and Thoughts about Clinical Research Requirements of Transdermal Patches in the US and Europe
  
DOI:doi:10.16153/j.1002-7777.2022.06.015
中文关键词: 透皮贴剂  临床研究  创新药  改良型新药  仿制药
英文关键词: transdermal patch  clinical research  innovative drugs  modifi ed drugs  generic drugs
基金项目:
作者单位
李金洲 烟台大学新型制剂与生物技术药物研究山东省高校协同创新中心,分子药理和药物评价教育部重点实验室(烟台大学),烟台 264005 
马文艳 绿叶制药集团有限公司,烟台 264003 
米璇 绿叶制药集团有限公司,烟台 264003 
由春娜 烟台大学新型制剂与生物技术药物研究山东省高校协同创新中心,分子药理和药物评价教育部重点实验室(烟台大学),烟台 264005 
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中文摘要:
      目的:为我国透皮贴剂的研发提供参考。方法:通过查阅美国和欧盟药监机构官网,就欧美关于透皮贴剂临床研究的要求及已上市透皮贴剂产品案例进行讨论和分析。结果与结论:结合欧美经验及我国法规现状,对我国透皮贴剂创新药、改良型透皮贴剂和透皮贴剂仿制药的临床研究要求分别提出了相应的思考建议:透皮贴剂创新药需开展充分的体内外研究以揭示其安全性和有效性;改良型透皮贴剂应与对照药开展桥接试验,并侧重于揭示经皮给药的临床特点和特有的不良反应;透皮贴剂仿制药可开展生物等效性试验、黏附性、皮肤刺激性和致敏性研究。
英文摘要:
      Objective: To provide references for the research and development of transdermal patches in China. Methods: By referring to the offi cial websites of US and EU drug regulatory agencies, the requirements of clinical research on transdermal patches and cases of marketed transdermal patches in Europe and the United States were discussed and analyzed. Results and Conclusion: Combined with the experience of Europe and the United States and the current situation of Chinese regulations, corresponding thoughts on the clinical research requirements of innovative drugs, modifi ed drugs, and generic drugs of transdermal patches in China are put forward. Transdermal patch innovations need to be fully studied in vitro and in vivo to reveal the safety and efficacy. The modified transdermal patch should carry out a bridging test with reference drugs, and focus on revealing the clinical characteristics and specific adverse reactions of transdermal delivery. Transdermal patch generics could be subjected to bioequivalence tests (BE), adhesion, skin irritation, and sensitization studies.
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