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美国药品审评程序的重要改变,往往和重大的药品事故有关。FIAU(fialuridine)是试验用化合物,处于乙型肝炎的Ⅱ期临床,是一种核苷的同系物,由纽约Memo rial Sloan-Kettering癌症中心于1985年和Bristol-My ers一起首先试验开发。1988年Memorial中心发给Oclassen开发证书,1992年Oclassen又把上市权卖给了Eli Lilly公司,交换条件之一是公司要资助进一步的开发。 国立卫生研究所(NIH)以Hoofnagle博士为主要研究人员,开始做Ⅱ期研究。Eli Lilly药厂还预计在1993年秋开始包括几千名病人的大规模置期试验。 1993年初,Hoofnagle博士对服FIAU4周的乙型肝炎病人观察证明,抗乙型肝炎用药中FIAU是作用最强的,并断言此试验未出现严重药品不良反应。由此他安排了一个新试验,时间延续24周,使用大剂量的FIAU。1993年6月在新受试的15位病人中,有几个出现了肝衰竭,FIAU事故开始明显化,15位中
Important changes in the U.S. drug review process are often associated with major drug incidents. FIAU (fialuridine) is a test compound that is in phase II clinical trial of hepatitis B and is a congener of nucleosides developed first with the Bristol-Myers in 1985 by the Memoiral Sloan-Kettering Cancer Center in New York City. The Memorial Center issued the Oclassen Developer Certificate in 1988, and Oclassen sold the listing to Eli Lilly in 1992, one of the terms of which was for the company to fund further development. National Institutes of Health (NIH) Dr Hoofnagle as the main researcher, began to do phase Ⅱ study. Eli Lilly also expects to begin a large-scale phase-out trial of thousands of patients in the fall of 1993. In early 1993, Dr. Hoofnagle’s observation of hepatitis B patients who took FIAU for 4 weeks showed that FIAU was the most effective anti-hepatitis B drug and concluded that there was no serious adverse drug reaction in this test. As a result, he arranged a new trial that lasted 24 weeks and used a large dose of FIAU. Of the 15 newly admitted patients in June 1993, hepatic failure occurred and several of the FIAU incidents began to clear. Of 15