Accelerated approval of medicines: fit for purpose?

被引：3
|
作者：
Breckenridge, Alasdair [1 ]
Liberti, Lawrence [2 ]
机构：
[1] Univ Liverpool, Dept Pharmacol & Therapeut, Ashton St, Liverpool L69 3BX, Merseyside, England
[2] Ctr Innovat Regulatory Sci, Friars House,160 Blackfriars Rd, London SE1 8EZ, England
来源：
NATURE REVIEWS DRUG DISCOVERY | 2018年 / 17卷 / 06期
关键词：
D O I：
10.1038/nrd.2017.245
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：
The uptake of a new medicine represents a balance between benefit-risk assessment and value considerations. In the case of products approved via accelerated pathways, the increased uncertainty adds to the challenge. Here, we suggest solutions so that regulators, companies, payers and patients can align around management of the uncertainties and expectations.
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页码：379 / 380
页数：2
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