仿制药和原研药,究竟有没有区别? 仿制药的一致性评价,又到底是什么?你知道药物创新, 原来也是分等级的吗? 而中国在药物自主研发上, 是否已经迈出第一步了呢?
欢迎您收看《抗生素的故事》系列影片, 第十五集, 虽然挂在《中国抗生素发展史》名下,但其实讲仿制药一不小心讲high了的下篇:自主的创新。
参考资料表:
Krystal, A.,et al. (2018). The first implementation of the NIMH FAST-FAIL approach to psychiatric drug development. Nature Reviews Drug Discovery, 18, 82-84. https://doi.org/10.1038/nrd.2018.222.
蔡年生(2021), 《中国抗生素发展纪事:60年的时间与见证》, 北京:化学工业出版社,ISBN: 978-7-122-38261-0.
范瑾 赵敏(2019), 一个氨基糖苷类创新药物依替米星的研发和产业化. 中国抗生素杂志, 44(11): 1229-1231
Bulman, Z., et al.(2020). Unraveling the Gentamicin Drug Product Complexity Reveals Variation in Microbiological Activities and Nephrotoxicity. Antimicrobial Agents and Chemotherapy, 64. https://doi.org/10.1128/AAC.00533-20.
Davit, B., et al.(2009). Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration. Annals of Pharmacotherapy, 43, 1583 - 1597. https://doi.org/10.1345/aph.1M141.
Tamboli, A., et al. (2010). An Overview on Bioequivalence: Regulatory Consideration for Generic Drug Products. Journal of Bioequivalence & Bioavailability, 2, 086-092. https://doi.org/10.4172/JBB.1000037.
《屠呦呦传》编写组 (2016),《屠呦呦传》,三联书店(香港)有限公司,ISBN:9789620439018
王满元 (2015),《呦呦与青蒿》, 人民卫生出版社, ISBN:9787117218917
Whitman, M., & Tunkel, A. (1992). Azithromycin and clarithromycin: overview and comparison with erythromycin.. Infection control and hospital epidemiology, 13 6, 357-68 . https://doi.org/10.1086/646545.
Li, D., Li, H., Ni, X., Zhang, H., & Xia, H. (2013). Construction of a gentamicin C1a-overproducing strain of Micromonospora purpurea by inactivation of the gacD gene.. Microbiological research, 168 5, 263-7. https://doi.org/10.1016/j.micres.2012.12.006.
闫素英 鲁开智 王传功 (2019),《药理学》(第4版),人民卫生出版社,ISBN:9787117269803