Ehrlich G E
J Clin Pharmacol. 1977 Nov-Dec;17(11-12):697-703. doi: 10.1002/j.1552-4604.1977.tb01544.x.
Guidelines have been developed by the Bureau of Drugs, FDA, for antinflammatory drug development. They address the problem of efficacy and safety testing but leave the definition of qualified investigators and appropriate subjects unstated. The natural history of rheumatoid arthritis, the most-studied chronic inflammatory disorder, is not sufficiently appreciated, and "controlled" studies are too narrowly structured to give adequate information. By contrast, other countries speed the review process by emphasizing early toxicity studies and letting the market place determine relative efficacy while long-range safety data are carefully monitored.
美国食品药品监督管理局药品局已制定了抗炎药物研发指南。这些指南解决了疗效和安全性测试问题，但未明确合格研究者和合适受试者的定义。类风湿关节炎是研究最多的慢性炎症性疾病，其自然病程未得到充分认识，而且“对照”研究的结构过于狭窄，无法提供足够信息。相比之下，其他国家通过强调早期毒性研究并让市场决定相对疗效，同时仔细监测长期安全性数据，加快了审评进程。
