研究的方法_{新药发明与研发}

潜在药物的发明

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潜在药物研发

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接下来，将在人类身上开展三个阶段的临床研究：

阶段1旨在确认该分子的安全性、它在人体内的作用方式以及可能产生的副作用。本研究的参与者均为健康志愿者（而不是目标疾病的患者），通常需要的人数为20到80人。

阶段2标志着就实际患有该疾病的患者开展的对照试验的开始，目的是要证明该药物的疗效。患者的总数仍然很小，或许只有几百人。这一阶段还会产生有关潜在新药物的短期副作用和相关风险的更多信息。

阶段3寻求通过从几百到几千不等的大量疾病患者，提供关于药物疗效和安全性的确切证据。这一广泛的数据可为根据普通人群推断相关结果以及产品随附的标签信息提供依据。