Gelzer J
Arch Toxicol. 1979 Oct;43(1):19-26. doi: 10.1007/BF00695870.
The science of toxicology has become infinitely more complex and sophisticated over the past 20 years, a trend which has been particularly marked within the research-based pharmaceutical industry. Governmental rules and regulations have had a strong impact on the types of toxicity test now performed on drugs both in the course of their development and after their introduction on the market, and have thus contributed to the increased cost--in terms of time and money--of drug development. However, it will never be possible to measure or predict the safety of drugs in man by the application of toxicological techniques alone. Close collaboration between toxicologists and the authorities responsible for drawing up toxicological regulations is called for in order to ensure that the rules applied during the important and fascinating process of discovering and developing new drugs do not become unnecessarily burdensome.
在过去20年里，毒理学这门科学变得极其复杂和精细，这一趋势在以研究为基础的制药行业中尤为明显。政府的规章制度对目前在药物研发过程中和上市后进行的毒性测试类型产生了重大影响，从而在时间和金钱方面导致了药物研发成本的增加。然而，仅靠应用毒理学技术永远无法衡量或预测药物对人类的安全性。毒理学家与负责制定毒理学法规的当局之间需要密切合作，以确保在发现和开发新药这一重要且引人入胜的过程中所应用的规则不会变得过于繁琐。
