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美国新药审批制度也许是世界上最严格的。现介绍一种药物是如何试验和审批的。临床前试验——某种有希望的药剂进行广泛的实验和动物试验以便确定:该化合物是否有生物活性?它是安全吗?如果这两方面的回答都是肯定的,那末药物申请人就要准备进行人体试验。这一阶段通常持续一到二年。
The U.S. drug approval system may be the most stringent in the world. Here is how a drug is tested and approved. Preclinical testing - a promising drug A wide range of laboratory and animal tests are conducted to determine if the compound is biologically active and is it safe? If both are positive, then the drug applicant will have to Ready for human testing. This phase usually lasts one to two years.