新药研究的监管方面。

Am J Hosp Pharm. 1978 Jan;35(1):81-5.

Federal regulations governing the introduction of new drugs in the United States are reviewed. The discussion includes the legislative background, what constitutes a "new drug," drug development, investigational new drugs, new drug applications, pharmacist involvement in clinical trials, the approval process and postmarketing surveillance.

对美国有关新药引入的联邦法规进行了审查。讨论内容包括立法背景、“新药”的构成、药物研发、研究性新药、新药申请、药剂师参与临床试验、审批过程以及上市后监测。