| 我国化学仿制药参比制剂遴选进展及其几点考虑 |
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| 引用本文： | 刘冬,李芳,安娜,哈莉莉,杨进波.我国化学仿制药参比制剂遴选进展及其几点考虑[J].中国临床药理学杂志,2021(6):783-787. |
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| 作者姓名： | 刘冬 李芳 安娜 哈莉莉 杨进波 |
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| 作者单位： | 国家药品监督管理局药品审评中心 |
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| 基金项目： | 国家“十三五”重大专项课题基金资助项目(2017ZX09101001)。 |
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| 摘 要： | 本研究通过对2017年3月至2020年10月我国化学仿制药参比制剂遴选及发布情况的梳理,初步分析近几年来已发布参比制剂品种的主要特征,结合参比制剂遴选过程中遇到的多种情况提出一般考虑。为有序推进化学仿制药参比制剂遴选以及一致性评价提供科学依据与参考。
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| 关 键 词： | 化学仿制药 参比制剂 进展 考虑 |
Progress and consideration of reference selection of chemical generic drugs in China |
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| LIU Dong,LI Fang,AN Na,HA Li-li,YANG Jin-bo.Progress and consideration of reference selection of chemical generic drugs in China[J].The Chinese Journal of Clinical Pharmacology,2021(6):783-787. |
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| Authors: | LIU Dong LI Fang AN Na HA Li-li YANG Jin-bo |
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| Affiliation: | (Center for Drag Evaluation National Medical Products Administration,Beijing J00022y China) |
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| Abstract: | By combing the reference selection of chemical generic drugs from March 2017 to October 2020 in China, this paper systematically analyzed the main features of published reference in recent years. Combined with the reference selection encountered variety situations, it puts forward some considerations and prospects provided scientific basis and reference which for pushing chemical generic reference selection and consistency evaluation. |
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| Keywords: | chemical generic drug reference progress consideration |
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