美国医药产品毒理学评价

Toxicological Assessment of Pharmaceutical Products in the United States

毒理学是研究化学或物理因素对生物系统有害作用的学科,是与制药工业关系最密切的学科之一,在新药的研究开发中起着重要的作用。任何药物不仅要有治疗作用,即有效性,还必须同时具备安全性,安全性评价是新药开发与审批的核心内容之一,是通过毒理学和临床研究,结合药物的作用与用途,对其临床使用的安全程度做出判断的过程。药物安全性评价包括毒理学评价和临床安全性评价两部分。药物的安全性最终要经临床试验予以肯定,但为保障受试者安全。

Since the United States has the largest pharmaceutical market in the world,toxicological as- sessment of pharmaceutical products is a complicated and stringently regulated process in the US,and it is of strategic importance for any pharmaceutical business to have a share in the influential US market.To this end,it is essential to have an in-depth understanding of the practice of drug safety assessment and regulatory requirements in the US.