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在美国,一种新药批准在市场销售需要数年.一只在实验室和在动物试验中发现一种新化合物具有生物活性和安全性,制药公司便向食品和药物管理局(FDA)提出申请,要求开始进行临床试验.即人体试验.如果FDA在30天内没有表示反对,此申请(称为审查的新药或IND申请)开始生效. 临床试验分为3期: I期研究在少量健康人中进行,目的是确定药物的药理学作用,其安全剂量以及机体对药物的吸收.代谢和排泄情况,I期研究一般需一年以下.
In the United States, a new drug approval takes several years to markete.A pharmaceutical company has filed an application with the Food and Drug Administration (FDA) for the biological activity and safety of a new compound found in labs and in animal experiments , Which calls for the start of a clinical trial, ie, a human trial, which will come into force if the FDA does not object within 30 days (the new drug for review, or the IND application). The clinical trial is divided into three phases: Phase I studies in a small number of healthy individuals The purpose is to determine the pharmacological effects of the drug, its safe dose and the body’s absorption of the drug. Metabolism and excretion, Phase I studies are generally required to be less than one year.