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.

引用

页码：379 / 380

页数：2

共 50 条

[41] Slowing down accelerated approval
不详
[J]. NATURE REVIEWS DRUG DISCOVERY, 2011, 10 (03) : 165 - 165
[42] Accelerated approval requirements for lurbinectedin
Benjamin, David J.
Prasad, Vinay
[J]. LANCET ONCOLOGY, 2022, 23 (05): : E206 - E206
[43] External examining: fit for purpose?
Bloxham, Sue
Price, Margaret
[J]. STUDIES IN HIGHER EDUCATION, 2015, 40 (02) : 195 - 211
[44] Mouldy concrete is fit for purpose
Chaffey, Nigel
[J]. ANNALS OF BOTANY, 2018, 121 (07) : VI - VII
[45] Antiviral drugs fit for a purpose
Ming Luo
[J]. Nature, 2006, 443 : 37 - 38
[46] WHO working to be fit for purpose
Chan, Margaret
[J]. NATURE, 2011, 474 (7353) : 579 - 579
[47] Psychology degree - fit for purpose?
Trapp, Annie
[J]. PSYCHOLOGIST, 2010, 23 (10) : 787 - 787
[48] Chemeng education: fit for purpose
不详
[J]. TCE, 2009, (814): : 16 - 16
[49] WHO working to be fit for purpose
Margaret Chan
[J]. Nature, 2011, 474 : 579 - 579
[50] Accelerated Approval Is Not Conditional Approval Insights From International Expedited Approval Programs
Mehta, Gautam U.
de Claro, R. Angelo
Pazdur, Richard
[J]. JAMA ONCOLOGY, 2022, 8 (03) : 335 - 336

← 1 2 3 4 5 →