Next-Generation Medicines: Past Regulatory Experience and Considerations for the Future

被引：16
|
作者：
Pacanowski, M. A. [1 ]
Leptak, C. [2 ]
Zineh, I. [1 ]
机构：
[1] US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA
[2] US FDA, Off New Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA
来源：
CLINICAL PHARMACOLOGY & THERAPEUTICS | 2014年 / 95卷 / 03期
关键词：
DRUG DEVELOPMENT;
D O I：
10.1038/clpt.2013.222
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
Application of personalized medicine in drug development and regulation has been limited by similar logistical, informatics, and cultural barriers that limit use of pharmacogenetics in the clinic. An additional challenge is coordinated codevelopment of new drugs and diagnostic tests. Nevertheless, the impact of personalized medicine strategies (e. g., pharmacogenomics) is being realized. We highlight some of our experiences to date and considerations for the development of the next generation of targeted therapies.
引用
收藏
页码：247 / 249
页数：4
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