The Tradeoff of Cancer Drug Regulatory Policy: Faster Approvals for One Means Less Knowledge for Another.
作者信息
Tao Derrick, Schott Sally, Prasad Vinay
机构信息
Department of Medicine, Oregon Health & Science University Portland.
Caregiver and Patient Advocate, Medford.
出版信息
Am J Med. 2019 Mar;132(3):e509-e511. doi: 10.1016/j.amjmed.2018.08.017. Epub 2018 Sep 7.
PMID:30201241
Abstract
摘要
相似文献
1
The Tradeoff of Cancer Drug Regulatory Policy: Faster Approvals for One Means Less Knowledge for Another.癌症药物监管政策的权衡：一种药物更快获批意味着另一种药物的了解减少。
Am J Med. 2019 Mar;132(3):e509-e511. doi: 10.1016/j.amjmed.2018.08.017. Epub 2018 Sep 7.
2
Cancer drug approval in the United States, Europe, and Japan.美国、欧洲和日本的癌症药物批准情况。
Adv Cancer Res. 2007;96:371-91. doi: 10.1016/S0065-230X(06)96012-6.
3
Food and Drug Administration responds to pressure for expanded drug access.美国食品药品监督管理局应对扩大药品可及性的压力。
J Natl Cancer Inst. 2014 Jun 6;106(6):dju171. doi: 10.1093/jnci/dju171. Print 2014 Jun.
4
Inappropriate use of progression-free survival in cancer drug approvals.癌症药物批准中无进展生存期的不当使用。
BMJ. 2020 Mar 10;368:m770. doi: 10.1136/bmj.m770.
5
Use of multiple endpoints and approval paths depicts a decade of FDA oncology drug approvals.多终点和审批途径的使用描绘了 FDA 肿瘤药物批准的十年历程。
Clin Cancer Res. 2013 Jul 15;19(14):3722-31. doi: 10.1158/1078-0432.CCR-13-0316. Epub 2013 May 10.
6
New Indications and Approvals for Anticancer Drugs.抗癌药物的新适应症与批准情况
Am J Nurs. 2021 Dec 1;121(12):16-17. doi: 10.1097/01.NAJ.0000803180.17463.0b.
7
Expanded Access Allows for Compassionate Use of Investigational Cancer Drugs.扩大使用允许对研究性癌症药物进行同情用药。
ONS Connect. 2015 Jun;30(2):47.
8
2011 FDA drug approvals.2011年美国食品药品监督管理局批准的药物
Nat Rev Drug Discov. 2012 Feb 1;11(2):91-4. doi: 10.1038/nrd3657.
9
Oncology approvals in 2020: a year of firsts in the midst of a pandemic.2020 年肿瘤学审批：大流行期间的首例之年。
Nat Rev Clin Oncol. 2021 Mar;18(3):129-130. doi: 10.1038/s41571-021-00477-1.
10
Neoadjuvant trials could speed up drug approvals.新辅助试验可以加快药物审批。
J Natl Cancer Inst. 2014 Mar;106(3):dju072. doi: 10.1093/jnci/dju072. Epub 2014 Mar 7.
Zotero 插件