| 晶型研究在口服固体制剂仿制药药学研发中的几点关注 |
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| 引用本文： | 杨文智,宁黎丽,许真玉.晶型研究在口服固体制剂仿制药药学研发中的几点关注[J].中国药学杂志,2022,57(15):1302-1304. |
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| 作者姓名： | 杨文智 宁黎丽 许真玉 |
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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 阐述晶型研究在口服固体制剂仿制药药学研发中的关注点。方法 通过对目前申报资料的分析和思考,对原料药和固体制剂中原料药的晶型研究的考虑和方法进行探讨。结果与结论 充分的晶型研究可以保证仿制药与参比制剂的治疗学等效以及仿制药的批间一致,是仿制药有效性、质量可控性的重要支持性研究。
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| 关 键 词： | 仿制药研发 晶型研究 口服固体制剂仿制药 |
| 收稿时间： | 2021-07-05 |
Pharmaceutical Concerns on the Polymorphism Study in the Development of Oral Solid Generic Drugs |
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| YANG Wen-zhi,NING Li-li,XU Zhen-yu.Pharmaceutical Concerns on the Polymorphism Study in the Development of Oral Solid Generic Drugs[J].Chinese Pharmaceutical Journal,2022,57(15):1302-1304. |
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| Authors: | YANG Wen-zhi NING Li-li XU Zhen-yu |
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| Institution: | Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China |
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| Abstract: | OBJECTIVE The concerns of the polymorphism study on the development of oral solid generic drugs were stated in this article. METHODS Based on the analysisand thinking of the dossiers, the consideration and methodology of the polymorphism study on the drug substance and the drug product were discussed. RESULT AND CONCLUSION The therapeutical equivalence between generic drugs and reference drugs, as well as the between-batch consistence of generic drugs, could be partially guaranteed by adequate polymorphism study, which are the important supporting study on the efficiency and quality controllability of generic drugs. |
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| Keywords: | generic drug development polymorphism study oral solid generic drug |
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