Stevens James L, Baker Thomas K
Division of Toxicology, Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285, United States.
Drug Discov Today. 2009 Feb;14(3-4):162-7. doi: 10.1016/j.drudis.2008.11.009. Epub 2009 Jan 3.
Drug safety remains a high profile issue at a time when the cost and time required to develop a new drug are at an all time high. Balancing risk against the expected clinical benefit is the primary purpose of preclinical and clinical testing. We offer an expanded view on the application of predictive strategies and technologies to early safety decisions and suggestions to narrow the focus for improving preclinical safety testing to the problems that contribute most to adverse drug reactions.
在开发一种新药所需的成本和时间处于历史高位之际,药物安全仍然是一个备受瞩目的问题。权衡风险与预期临床益处是临床前和临床试验的主要目的。我们对预测策略和技术在早期安全性决策中的应用提出了更广泛的观点,并给出了一些建议,以将改善临床前安全性测试的重点缩小到对药物不良反应贡献最大的问题上。