Beyond debacle and debate: developing solutions in drug safety

被引:15
作者
Ray, Amrit [1 ]
机构
[1] Bristol Myers Squibb Co, Res & Dev, Princeton, NJ 08543 USA
关键词
D O I
10.1038/nrd2988
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
In the 5 years since the Vioxx debacle, efforts have been made to enhance drug safety. These include the introduction of legislation that expands the power of drug regulatory agencies, new data transparency standards and increased requirements for funding of post-marketing drug surveillance. Nevertheless, some doubt remains that these changes will be sufficient to address the increasing challenges in the field of drug safety. Here, from the perspective of a drug researcher, I discuss key areas for further development that could deliver long-term solutions to these challenges: enhanced tools for the detection of safety signals, innovative phased drug launches, new risk stratification techniques and improved pharmacovigilance operations.
引用
收藏
页码:775 / 779
页数:5
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