FDA Takes On Personalized Medicine

Courtney Humphries

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FDA Takes On Personalized Medicine

机译：FDA接受个性化医学

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Personalized medicine does not fit easily into established government procedures for approving drugs. After all, clinical trials are designed to test a drug on a large and diverse group of patients, and the whole point of personalized therapeutics is to target the specific genetic populations that will benefit most. The U.S. Food and Drug Administration is now trying to figure out how to judge the usefulness of a drug designed for particular genetic groups while also considering its safety for others who may receive it for off-label purposes.

机译：个性化药物不容易适应政府批准药物的既定程序。毕竟，临床试验旨在针对大量不同的患者群测试药物，个性化治疗的重点是针对将受益最大的特定基因人群。美国食品药品监督管理局现在正试图弄清楚如何判断为特定遗传人群设计的药物的有效性，同时还要考虑其对可能出于标签外用途接受其他药物的安全性。

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《Technology review》 |2010年第4期|P.53|共1页
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Courtney Humphries;
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1. FDA Takes On Personalized Medicine [J] . Courtney Humphries Technology review . 2010,第2期

机译：FDA接受个性化医学
2. Prainsack , B . Personalized Medicine: Empowered Patients in the 21st Century? New York : New York University Press . 2017 . 288 pp. Prainsack , B Prainsack Prainsack , B B . Personalized Medicine: Empowered Patients in the 21st Century? Personalized Medicine: Empowered Patients in the 21st Century? New York New York : New York University Press New York University Press . 2017 2017 . 288 288 pp. [J] . Bartlett Andrew Sociology of health & illness . 2019,第7期

机译：prainsack，b。个性化医学：21世纪患者赋予患者？纽约：纽约大学出版社。 2017年。 288 PP。PraIseack，B Praseack PraIseack，B B。个性化医学：21世纪患者赋予患者？个性化医学：21世纪患者赋予患者？纽约纽约：纽约大学出版社纽约大学出版社。 2017年2017年。 288 288 pp。
3. CLAUDIO CARINI, SANDEEP M. MENON, AND MARK CHANG, EDS . Clinical and Statistical Considerations in Personalized Medicine . Boca Raton : CRC Press . CLAUDIO CARINI, SANDEEP M. MENON, AND MARK CHANG, EDS CLAUDIO CARINI, SANDEEP M. MENON, AND MARK CHANG, EDS . Clinical and Statistical Considerations in Personalized Medicine Clinical and Statistical Considerations in Personalized Medicine . Boca Raton Boca Raton : CRC Press CRC Press . [J] . Pfeiffer Ruth Biometrics: Journal of the Biometric Society : An International Society Devoted to the Mathematical and Statistical Aspects of Biology . 2018,第2期

机译：Claudio Carini，Sandeep M. Menon，以及Mark Chang，EDS。个性化医学中的临床和统计考虑因素。 Boca Raton：CRC压力机。 Claudio Carini，Sandeep M. Menon和Mark Chang，Eds Claudio Carini，Sandeep M. Menon，以及Mark Chang，EDS。个性化医学临床和统计考虑的个性化医学临床考虑。 Boca Raton Boca Raton：CRC按CRC压力机。
4. Establishing infrastructure in Personalized Medicine: The University of Maryland Program for Personalized and Genomic Medicine [C] . Shuldiner A.R., Pakyz R.E., Palmer K., International Congress on Personalized Medicine . 2014

机译：在个性化医学中建立基础设施：Maryland大学的个性化和基因组
5. Integrated Product and Production Platforms for Pharmaceutical Products: Design Thinking for the Development of Personalized Medicines [D] . Siiskonen, Maria Daniela Irene. 2019

机译：用于制药产品的综合产品和生产平台：设计思考个性化药物的发展
6. Accelerating evidence gathering and approval of precision medicine therapies: the FDA takes aim at rare mutations [O] . Amalia M. Issa, Adrian Thorogood, Yann Joly, -1

机译：加快精确医学疗法的证据收集和批准：FDA瞄准罕见突变
7. Bulletin: New findings show Vascepa significantly reduces cardiovascular events in high-risk patients; Pediatric telemedicine visits yield more antibiotic prescriptions; National data trends show long-term opioid prescriptions increased over time; FDA takes major step to lower insulin prices [O] . 2019

机译：公告：新发现显示Vascepa显着降低了高风险患者的心血管事件;儿科远程医疗访问产生更多的抗生素处方;国家数据趋势显示长期阿片类药物随着时间的推移而增加; FDA为降低胰岛素价格进行重大步骤

FDA Takes On Personalized Medicine

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