NIH, FDA seek lessons from hepatitis B drug trial deaths.
作者信息
Macilwain C
出版信息
Nature. 1993 Jul 22;364(6435):275. doi: 10.1038/364275d0.
DOI:10.1038/364275d0
PMID:8332178
Abstract
摘要
相似文献
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NIH, FDA seek lessons from hepatitis B drug trial deaths.美国国立卫生研究院（NIH）和美国食品药品监督管理局（FDA）从乙肝药物试验死亡事件中吸取教训。
Nature. 1993 Jul 22;364(6435):275. doi: 10.1038/364275d0.
2
Concern grows over reaction to deaths in clinical trials.对临床试验中死亡反应的担忧日益增加。
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Hepatitis study. Drug trial deaths deemed unavoidable.
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Panel clears NIH in patient deaths.专家组判定国立卫生研究院在患者死亡事件中无过错。
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Trial deaths prompt tighter rules.试验死亡促使规则更加严格。
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Mitochondrial toxicity--new adverse drug effects.
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Severe toxicity of fialuridine (FIAU).氟碘阿糖尿嘧啶（FIAU）的严重毒性
N Engl J Med. 1996 Apr 25;334(17):1136; author reply 1137-8.
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Severe toxicity of fialuridine (FIAU).
N Engl J Med. 1996 Apr 25;334(17):1136-7; author reply 1137-8.
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US health agencies at odds over trial deaths.
Nature. 1994 Jun 9;369(6480):433. doi: 10.1038/369433a0.
引用本文的文献
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Development of resistance and perspectives for future therapies against hepatitis B infections: lessons to be learned from HIV.乙型肝炎感染耐药性的发展及未来治疗前景：从艾滋病病毒中吸取的教训
Infection. 1999;27 Suppl 2:S45-51. doi: 10.1007/BF02561672.
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Fialuridine accumulates in DNA of dogs, monkeys, and rats following long-term oral administration.长期口服给药后，非阿尿苷会在狗、猴子和大鼠的DNA中蓄积。
Proc Natl Acad Sci U S A. 1994 Dec 6;91(25):12003-7. doi: 10.1073/pnas.91.25.12003.
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Sensitive and specific radioimmunoassay for fialuridine: initial assessment of pharmacokinetics after single oral doses to healthy volunteers.法米替定的灵敏且特异的放射免疫分析：单次口服给药健康志愿者后的药代动力学初步评估。
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