期刊
EXPERT REVIEW OF MOLECULAR DIAGNOSTICS
卷 15, 期 7, 页码 869-880出版社
TAYLOR & FRANCIS AS
DOI: 10.1586/14737159.2015.1045490
关键词
approval; cancer; companion diagnostics; FDA; personalized medicine
类别
Companion diagnostics are essential for the safe and effective use of the corresponding therapeutic products. The US FDA has approved a number of companion diagnostics used to select cancer patients for treatment with contemporaneously approved novel therapeutics. The processes of co-development and co-approval of a therapeutic product and its companion diagnostic have been a learning experience that continues to evolve. Using several companion diagnostics as examples, this article describes the challenges associated with the scientific, clinical and regulatory hurdles faced by FDA and industry alike. Taken together, this discussion is intended to assist manufacturers toward a successful companion diagnostics development plan.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据