Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011-2017: Lessons Learned for Anticancer Drug Development

被引：38
作者：
Faucette, Stephanie [1 ]
Wagh, Santosh [1 ]
Trivedi, Ashit [2 ]
Venkatakrishnan, Karthik [1 ]
Gupta, Neeraj [1 ]
机构：
[1] Millennium Pharmaceut Inc, Cambridge, MA 02139 USA
[2] Amgen Inc, Clin Pharmacol, Thousand Oaks, CA 91320 USA
来源：
CTS-CLINICAL AND TRANSLATIONAL SCIENCE | 2018年 / 11卷 / 02期
关键词：
CLINICAL-PHARMACOLOGY; HEPATIC IMPAIRMENT; RISK-ASSESSMENT; SAFETY; FDA; DISPOSITION; DECISIONS; DISEASE; IMPACT; TRIALS;
D O I：
10.1111/cts.12527
中图分类号：
R-3 [医学研究方法]; R3 [基础医学];
学科分类号：
1001 ;
摘要：
[No abstract available]
引用
收藏
页码：123 / 146
页数：24
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