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经过周密设计的动物实验和临床观察基本上能很好地反映出药物的毒副反应,但药品一旦上市后,经过广泛使用,仍然可能发生一些没有注意到的毒副反应,这些毒副反应甚至在数年到数十年的长时间内也未能查觉出来,非那西丁的肾病和心得宁的眼-腹膜严重损害就是两个范例。为了早期发现这种潜在毒性,防止危害的扩大,国外创建了一套药物安全监测系统,本文介绍它的兴起、发展、功能、监察范围、方法学和国际协作的重要性,作为我国实行药品全面质量的参考。
Well-designed animal experiments and clinical observations can basically reflect the side effects of drugs. However, once the drugs are widely used, some unidentified side effects may still occur after they are put on the market. These toxic side effects or even In a few years to a few decades also failed to detect out, phenacetin nephropathy and Ning Ning’s eyes - severe peritoneal damage is two examples. In order to detect this potential toxicity early and to prevent the harm from expanding, a set of drug safety monitoring system has been established abroad. This article introduces the importance of its rise, development, function, scope of monitoring, methodology and international cooperation. Quality reference.