| 张辉,赵建中,郭志鑫.美国化学药品治疗等效性评价体系的简介及启示[J].中国药事,2023,(7):843-848 |
| 美国化学药品治疗等效性评价体系的简介及启示 |
| Introduction and Enlightenment of the Evaluation System of Therapeutic Equivalence in the United States |
| 投稿时间：2022-11-16 |
| DOI：10.16153/j.1002-7777.2023.07.014 |
| 中文关键词: 化学药品 治疗等效性 评价 参比制剂 启示 |
| 英文关键词: chemical drugs therapeutic equivalence evaluation reference medical products inspiration |
| 基金项目: |
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| 摘要点击次数: 798 |
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| 中文摘要: |
| 目的：介绍美国《治疗等效性评价行业指南》的最新内容，梳理仿制药与原研药品治疗等效性的考量因素，以期为我国仿制药研发前参比制剂的选择提供借鉴。方法：通过阐述《联邦食品、药品和化妆品法案》中批准的多源处方药等效性类别及美国药品橙皮书中等效性药品的标记方式，分析橙皮书中等效性评估体系的认定原则和动态管理模式，为我国仿制药参比制剂的确定及管理提供借鉴。结果与结论：美国化学仿制药治疗等效性的判定原则以及治疗等效性代码在橙皮书中的使用，为我国化学仿制药研发中参比制剂的选择、治疗等效性评估及参比制剂的管理模式提供了借鉴。 |
| 英文摘要: |
| Objective: In order to provide references for the selection of reference medical products before the development of generic drugs in China, this paper introduces the latest content of “Evaluation of Therapeutic Equivalence Guidance for Industry” in the United States, and sorts out the factors to consider the equivalence of generic drugs and original drugs treatments. Methods: By introducing the equivalence categories of multi-source prescription drugs approved under the Federal Food, Drug, and Cosmetics Act (FD&C Act) and the labeling of equivalent drugs in the US drug orange book, the identifi cation principle and dynamic management mode of the equivalence evaluation system in the U.S. FDA Orange Book, were analyzed in order to provide ideas for the determination and management of reference medical products of generic drugs in China. Results and Conclusion: Judgment principle of therapeutic equivalence of chemical generic drugs in the United States and using the therapeutic equivalence code in the Orange Book, it provides reference for the selection, therapeutic equivalence evaluation and management mode of reference medical products in the development of chemical generic drugs in China. |
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