| 窄治疗指数药物人体生物等效性研究的几点考虑 |
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| 引用本文： | 刘冬,韩鸿璨,王骏.窄治疗指数药物人体生物等效性研究的几点考虑[J].现代药物与临床,2021,44(10):2262-2267. |
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| 作者姓名： | 刘冬 韩鸿璨 王骏 |
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| 作者单位： | 国家药品监督管理局 药品审评中心, 北京 100022 |
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| 摘 要： | 窄治疗指数（NTI）药物的定义与特点决定此类药物仿制药的生物等效性研究需建立更加科学、规范的研究设计与评价标准。对NTI药物的定义与特点进行了梳理，对不同监管机构公布的NTI药物进行整理，列出此类药物生物等效性研究具体要求；结合中国发布的《窄治疗指数药物生物等效性研究技术指导原则》相关内容，对NTI药物口服固体制剂生物等效性试验的审评提出几点考虑，以期为开展此类药物的生物等效性研究提供科学依据与参考。
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| 关 键 词： | 窄治疗指数药物 仿制药 生物等效性 口服固体制剂 药物评价 |
| 收稿时间： | 2021/6/16 0:00:00 |
Consideration of in vivo bioequivalence research for narrow therapeutic index drugs |
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| LIU Dong,HAN Hongcan,WANG Jun.Consideration of in vivo bioequivalence research for narrow therapeutic index drugs[J].Drugs & Clinic,2021,44(10):2262-2267. |
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| Authors: | LIU Dong HAN Hongcan WANG Jun |
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| Affiliation: | Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China |
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| Abstract: | The definition and characteristics of narrow therapeutic index (NTI) drugs determine the bioequivalence research of such chemical generic drugs needs more scientific and standard research design and evaluation criteria. In this paper, the list of published NTI drug and requirements for bioequivalence research of international regulatory agencies and China were reviewed. Combined with published NTI drugs bioequivalence research technical guidance of China,considerations were put forward in combination with the BE review of NTI solid oral preparations, in order to provide scientific reference for the bioequivalence research of NTI drugs. |
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| Keywords: | narrow therapeutic index (NTI) drugs generic drug bioequivalence oral solid preparation drug evaluation |
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