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Balancing safety, effectiveness, and public desire: the FDA and cancer.

作者信息

Conti Rena

机构信息

John F. Kennedy School of Government, USA.

出版信息

Issue Brief (Commonw Fund). 2003 Apr(615):1-6.

PMID:12693391
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4591854/
Abstract
摘要

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本文引用的文献

1
Testing of new agents in childhood cancer preclinical models: meeting summary.儿童癌症临床前模型新药物测试:会议总结
Clin Cancer Res. 2002 Dec;8(12):3646-57.
2
The promise and peril of surrogate end points in cancer research.
Nat Rev Cancer. 2002 Jan;2(1):19-27. doi: 10.1038/nrc702.
3
The case for a new national program for the development of cancer therapeutics.关于制定一项新的国家癌症治疗研发计划的理由。
J Clin Oncol. 2001 Jun 15;19(12):3142-53. doi: 10.1200/JCO.2001.19.12.3142.
4
Relationships between drug activity in NCI preclinical in vitro and in vivo models and early clinical trials.美国国立癌症研究所临床前体外和体内模型中的药物活性与早期临床试验之间的关系。
Br J Cancer. 2001 May 18;84(10):1424-31. doi: 10.1054/bjoc.2001.1796.
5
Biomarkers and surrogate endpoints: preferred definitions and conceptual framework.生物标志物与替代终点:首选定义及概念框架
Clin Pharmacol Ther. 2001 Mar;69(3):89-95. doi: 10.1067/mcp.2001.113989.
6
Molecules for the millennium: how will they look? New drug discovery year 2000.千禧年的分子:它们会是什么样子?2000年新药研发
Br J Cancer. 2000 Dec;83(11):1401-4. doi: 10.1054/bjoc.2000.1473.
7
Evolving approaches to cancer drug discovery and development at the National Cancer Institute, USA.美国国立癌症研究所癌症药物发现与开发的不断演进的方法。
Ann Oncol. 1999 Nov;10(11):1287-91. doi: 10.1023/a:1008333901925.
8
Anticancer agents targeting signaling molecules and cancer cell environment: challenges for drug development?靶向信号分子和癌细胞环境的抗癌药物:药物研发面临的挑战?
J Natl Cancer Inst. 1999 Aug 4;91(15):1281-7. doi: 10.1093/jnci/91.15.1281.
9
Pediatric drug development: a perspective from the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI).儿科药物研发:来自美国国立癌症研究所(NCI)癌症治疗评估项目(CTEP)的观点
Invest New Drugs. 1996;14(1):11-22. doi: 10.1007/BF00173678.