| 2019年美国FDA批准上市的新药简介 |
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| 引用本文： | 吕训磊,周伟澄,林快乐. 2019年美国FDA批准上市的新药简介[J]. 中国医药工业杂志, 2020, 0(1): 1-29 |
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| 作者姓名： | 吕训磊 周伟澄 林快乐 |
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| 作者单位： | 中国医药工业研究总院上海医药工业研究院创新药物与制药工艺国家重点实验室上海市抗感染药物研究重点实验室 |
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| 摘 要： | 2019年美国食品药品监督管理局(FDA)批准上市新药48个,其中化学小分子38个、生物制品10个.本文根据FDA批准的新药说明书以及相关文献和专利情况,简要介绍化学小分子药物的概况、适应证、作用机制、剂型规格、不良反应和合成路线等,以及生物制品的相关情况.
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| 关 键 词： | 美国FDA 新药批准 适应证 合成路线 |
Overviews of the New Drugs in 2019 Approved by U.S. FDA |
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| LÜXunlei,ZHOU Weicheng,LIN Kuaile. Overviews of the New Drugs in 2019 Approved by U.S. FDA[J]. Chinese Journal of Pharmaceuticals, 2020, 0(1): 1-29 |
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| Authors: | LÜXunlei ZHOU Weicheng LIN Kuaile |
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| Affiliation: | (Shanghai Key Lab.of Anti-infectives,State Key Lab.of New Drug and Pharmaceutical Process,Shanghai Institute of Pharmaceutical Industry,China State Institute of Pharmaceutical Industry,Shanghai 201203) |
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| Abstract: | The U.S. Food and Drug Administration(FDA) approved 48 new drugs into the market in 2019, including 38 chemical small molecules and 10 biological products. According to the prescription information for professionals and the related literature as well as patent information, this review describes the descriptions, indications, mechanism of action, dosage form and strength, adverse reactions, and one synthetic route of the chemical small molecules, and brief information about biological products. |
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| Keywords: | the U.S. FDA new drug approval indication synthetic route |
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