| 口服调释类仿制药乙醇诱导的剂量倾泻研究探讨 |
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| 引用本文： | 魏赫,李雪梅.口服调释类仿制药乙醇诱导的剂量倾泻研究探讨[J].中国药学杂志,2022,57(3):209-213. |
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| 作者姓名： | 魏赫 李雪梅 |
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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： | 目的 探讨口服调释类仿制药研发中乙醇诱导的剂量倾泻研究要求.方法 结合审评实际情况,对口服调释类仿制药乙醇诱导的剂量倾泻研究中常见问题进行了分析,总结了国内外药品监管机构相关的技术要求,提出了研究建议.结果 与结论乙醇可能会改变调释制剂药物释放特性,带来用药安全性和有效性问题.建议口服调释类仿制药研发时予以关注,并进行...
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| 关 键 词： | 调释制剂 乙醇诱导 剂量倾泻 药物研发 关键质量属性 体外评价 |
| 收稿时间： | 2021-09-23 |
Discussion on Alcohol-induced Dose Dumping in the Development of Generic Oral Modified-Release Preparations |
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| WEI He,LI Xue-mei.Discussion on Alcohol-induced Dose Dumping in the Development of Generic Oral Modified-Release Preparations[J].Chinese Pharmaceutical Journal,2022,57(3):209-213. |
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| Authors: | WEI He LI Xue-mei |
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| Institution: | Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China |
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| Abstract: | OBJECTIVE To discuss the the requirements of alcohol-induced dose dumping in the development of generic oral modified-release preparations. METHODS Based on the review, the common problems on alcohol-induced dose dumping in the development of generic oral modified-release preparations were analyzed, the recommendations on dose dumping of domestic and foreign drug regulatory authorities were summarized, and general considerations were put forward. RESULTS AND CONCLUSION Alcohol may alter the release characteristics of modified-release preparations and cause safety and effectiveness problems. In vitro studies are recommended to evaluate the possibility of sudden drug release(dose dumping) in the presence of alcohol in vivo. |
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| Keywords: | modified-release preparations alcohol-induced dose dumping drug development critical quality attribute in vitro evaluation |
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