那他珠单抗治疗多发性硬化症给临床试验带来的经验教训。
Lessons for clinical trials from natalizumab in multiple sclerosis.
作者信息
Chaudhuri Abhijit
机构信息
Essex Centre for Neurological Sciences, Oldchurch Hospital, Romford RM7 0BE.
出版信息
BMJ. 2006 Feb 18;332(7538):416-9. doi: 10.1136/bmj.332.7538.416.
Abstract
The approval of natalizumab and its recall after three months raises questions about the fast tracking of new drugs by the Food and Drug Administration for commercial licensing
摘要
那他珠单抗的获批及其在三个月后被召回引发了关于美国食品药品监督管理局对新药进行快速商业许可审批的质疑。
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