| 以药动学方法评价的抗精神分裂症药物人体生物等效性研究的一般考虑 |
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| 引用本文： | 李娜,韩鸿璨,王骏. 以药动学方法评价的抗精神分裂症药物人体生物等效性研究的一般考虑[J]. 金属学报, 2021, 26(12): 1419-1425. DOI: 10.12092/j.issn.1009-2501.2021.12.012 |
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| 作者姓名： | 李娜 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： | 基于抗精神分裂症药物的特点,结合国内外不同监管机构对抗精神分裂症仿制药的生物等效性研究技术指导原则要求,以部分药物为例,从试验设计的角度讨论其在开展生物等效性研究时的考虑要点,为相关产品的研发和评价提供一定参考。
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| 关 键 词： | 精神分裂症 仿制药 生物等效性研究 氯氮平 富马酸喹硫平 |
| 收稿时间： | 2021-11-10 |
| 修稿时间： | 2021-11-24 |
General considerations for bioequivalence studies with pharmacokinetic methods for anti-schizophrenic drugs |
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| LI Na,HAN Hongcan,WANG Jun. General considerations for bioequivalence studies with pharmacokinetic methods for anti-schizophrenic drugs[J]. Acta Metallurgica Sinica, 2021, 26(12): 1419-1425. DOI: 10.12092/j.issn.1009-2501.2021.12.012 |
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| Authors: | LI Na HAN Hongcan WANG Jun |
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| Affiliation: | Center of Drug Evaluation, National Medical Products Administration, Beijing 100022, China |
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| Abstract: | On account of the characteristics of anti-schizophrenic drugs, combined with the technical guidelines for bioequivalence studies of anti-schizophrenic generic drugs in different regulatory institutions at home and abroad, taking some drugs as examples, this paper discusses the key points to be considered in carrying out bioequivalence studies from the perspective of experimental design, so as to provide certain reference for the research and development and evaluation of related products. |
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| Keywords: | schizophrenia generic drugs bioequivalence studies clozapine quetiapine fumarate |
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