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Homoharringtonine/Omacetaxine Mepesuccinate: The Long and Winding Road to Food and Drug Administration Approval

机译：同型harringtonington / omenacetaxine Mepesuccinate：食品药品监督管理局批准的漫长而曲折的道路

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Homoharringtonine/omacetaxine is a unique agent with a long history of research development. It has been recently approved by the Food and Drug Administration for the treatment of chronic myeloid leukemia after failure of 2 or more tyrosine kinase inhibitors. Research with this agent has spanned over 40 years, with many instructive lessons to cancer research, which are summarized in this review.

机译：同型harringtonington / omacetaxine是具有悠久研究开发历史的独特药物。食品和药物管理局最近批准了它用于治疗2种或更多种酪氨酸激酶抑制剂失败后的慢性粒细胞白血病。使用这种药物的研究已经跨越了40多年，对癌症研究提供了许多指导性的经验教训，本综述对此进行了总结。

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期刊名称 other
作者
Hagop M. Kantarjian; Susan O’Brien; Jorge Cortes;
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年(卷),期 -1(13),5
年度 -1
页码 530–533
总页数 7
原文格式 PDF
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专利

1. U.S. Food and drug administration approval summary: Omacetaxine mepesuccinate as treatment for chronic myeloid leukemia [J] . AlvandiF., KwitkowskiV.E., KoC.-W., The oncologist . 2014,第1期

机译：美国食品和药物管理局批准摘要：奥美西他滨琥珀酸酯用于治疗慢性粒细胞白血病
2. U.S. Food and Drug Administration Approval Summary: Omacetaxine Mepesuccinate as Treatment for Chronic Myeloid Leukemia [J] . Ann T. Farrell, Chia-Wen Ko, Debasis Ghosh, The oncologist . 2014,第1期

机译：美国食品和药物管理局批准摘要：奥美西他滨琥珀酸酯作为治疗慢性粒细胞白血病的方法
3. Telavancin: The Long and Winding Road From Discovery to Food and Drug Administration Approvals and Future Directions [J] . Wenzler Eric, Rodvold Keith A. Clinical infectious diseases . 2015,第Suppla2期

机译：特拉万星：从发现到食品和药物管理局批准的漫长曲折道路和未来方向
4. Investigating the Food and Drug Administration (FDA) Biotherapeutics Review and Approval Process: A Scoping Review [C] . Samuel A. Bonet, Farzan Sasangohar, Mark Lawley Human Factors and Ergonomics Society annual meeting . 2018

机译：调查食品和药物管理局（FDA）生物治疗审查和审批过程：审查审查
5. The Food and Drug Administration's new drug approvals and market withdrawals for safety under the Prescription Drug User Fee Act and the Food and Drug Modernization Act. [D] . Dziurzynski, Bogdan. 2005

机译：食品和药物管理局根据《处方药使用者费用法》和《食品和药物现代化法》为安全起见批准了新药，并撤出了市场。
6. U.S. Food and Drug Administration Approval Summary: Omacetaxine Mepesuccinate as Treatment for Chronic Myeloid Leukemia [O] . Firoozeh Alvandi, Virginia E. Kwitkowski, Chia-Wen Ko, 2014

机译：美国食品和药物管理局批准摘要：奥美西他滨琥珀酸酯作为治疗慢性粒细胞白血病的方法
7. Homoharringtonine/Omacetaxine Mepesuccinate: The Long and Winding Road to Food and Drug Administration Approval [O] . Hagop M. Kantarjian, Susan OBrien, Jorge Cortes 2013

机译：HomoHarringtonine / Omacetaxine Mepesucine：漫长而蜿蜒的食品和药物管理局批准
8. Food and Drug Administration: Food Additive Approval Process Followed for Aspartame [R] . 1987

机译：食品和药物管理局：阿斯巴甜遵循食品添加剂批准程序

Homoharringtonine/Omacetaxine Mepesuccinate: The Long and Winding Road to Food and Drug Administration Approval

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