论文部分内容阅读
1989年美国食品与药物管理局(FDA)批准23种新药上市,平均复审时间2.7年。FDA对于药物效果有一项等级制,1A说明这些药物获得重要疗效;1B为中等疗效;1C为很少或没有疗效;1,4C说明联合用药获得微弱的治疗效果。23种新产品及其用途如下: ·Flutamide,Schering公司生产,商品名Eulexin。用于治疗转移性前列腺癌。(1B) ·Cefpiramide Sodium,Wyeth Ayerts公司生产,无商品名,治疗肺炎、皮肤及皮肤组织感染。(1C)
In 1989 the United States Food and Drug Administration (FDA) approved 23 kinds of new drugs market, the average review time of 2.7 years. The FDA has a hierarchy of drug effects, with 1A indicating that these drugs have significant efficacy; 1B with moderate efficacy; 1C with little or no efficacy; and 1,4 C with weak effects of combination therapy. The 23 new products and their uses are as follows: Flutamide, manufactured by Schering Corporation under the trade name Eulexin. For the treatment of metastatic prostate cancer. (1B) · Cefpiramide Sodium, manufactured by Wyeth Ayerts Company, under the trade name No treatment for pneumonia, skin and skin infections. (1C)