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

Faucette Stephanie; Wagh Santosh; Trivedi Ashit; Venkatakrishnan Karthik; Gupta Neeraj

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

机译：2011-2017批准的美国食品和药物管理局核查新分子实体的反向翻译：抗癌药物发展的经验教训

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《Clinical and translational science.》 |2018年第2期|共24页
作者
Faucette Stephanie; Wagh Santosh; Trivedi Ashit; Venkatakrishnan Karthik; Gupta Neeraj;
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作者单位

Millennium Pharmaceut Inc Cambridge MA 02139 USA;

Millennium Pharmaceut Inc Cambridge MA 02139 USA;

Amgen Inc Clin Pharmacol Thousand Oaks CA 91320 USA;

Millennium Pharmaceut Inc Cambridge MA 02139 USA;

Millennium Pharmaceut Inc Cambridge MA 02139 USA;

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原文格式 PDF
正文语种 eng
中图分类临床医学;
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1. Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011-2017: Lessons Learned for Anticancer Drug Development [J] . Faucette Stephanie, Wagh Santosh, Trivedi Ashit, Clinical and translational science. . 2018,第2期

机译：2011-2017批准的美国食品和药物管理局核查新分子实体的反向翻译：抗癌药物发展的经验教训
2. Food Effect Study Design With Oral Drugs: Lessons Learned From Recently Approved Drugs in Oncology [J] . Farha Mark, Masson Eric, Tomkinson Helen, The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology . 2019,第4期

机译：食物效果研究设计与口腔药物：从最近批准的肿瘤学毒品中吸取的经验教训
3. Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014 [J] . Pinnow Ellen, Amr Sania, Bentzen Soren M., Clinical Pharmacology and Therapeutics . 2018,第2期

机译：新分子实体（NME）批准的新分子实体的安全结果（NME）2002年至2014年批准的食品和药物管理局
4. Opportunity to Grow and Explore: Lessons from a Bioinnovation Graduate Student Summer Internship Program at the U.S. Food and Drug Administration [C] . Anne-Marie Jacob Job, Rebecca Zarch, Alan R. Peterfreund American Society for Engineering Education Annual Conference and Exposition . 2017

机译：成长和探索的机会：来自美国食品和药物管理局的生物进一步研究生夏季实习计划的课程
5. The Food and Drug Administration's new drug approvals and market withdrawals for safety under the Prescription Drug User Fee Act and the Food and Drug Modernization Act. [D] . Dziurzynski, Bogdan. 2005

机译：食品和药物管理局根据《处方药使用者费用法》和《食品和药物现代化法》为安全起见批准了新药，并撤出了市场。
6. Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011–2017: Lessons Learned for Anticancer Drug Development [O] . Stephanie Faucette, Santosh Wagh, Ashit Trivedi, 2018

机译：美国食品和药物管理局的反向翻译肿瘤学新分子实体在2011-2017年获批复：抗癌药物开发的经验教训
7. Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011-2017: Lessons Learned for Anticancer Drug Development [O] . Stephanie Faucette, Santosh Wagh, Ashit Trivedi, 2017

机译：2011-2017批准的美国食品和药物管理局核查新分子实体的反向翻译：抗癌药物发展的经验教训

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

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