Lasagna L
Center for the Study of Drug Development, Tufts University, Boston, Massachusetts.
Drugs Exp Clin Res. 1987;13(11):659-64.
In considering post-registration research, the paper deals with the motivation of the interested parties for such research, new uses for established drugs, ways of filling information gaps and concludes with a number of fundamental principles on which post-registration research should be based.
在考虑注册后研究时,本文探讨了相关各方开展此类研究的动机、已上市药物的新用途、填补信息空白的方法,并以注册后研究应基于的一些基本原则作为结论。