Biomarkers and Surrogate Endpoints in Drug Development: A European Regulatory View

Wickstrom Kerstin; Moseley Jane

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Biomarkers and Surrogate Endpoints in Drug Development: A European Regulatory View

机译：药物发展中的生物标志物和替代终点：欧洲监管观

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PURPOSE. To give a European regulatory overview of the requirements on and the use of biomarkers or surrogate endpoints in the development of drugs for ocular disease.

机译：目的。为欧洲监管概述概述生物标志物或使用替代终点在发育眼部疾病的药物方面。

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来源
《Investigative ophthalmology & visual science》 |2017年第6期|共7页
作者
Wickstrom Kerstin; Moseley Jane;
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作者单位

Med Prod Agcy Dag Hammarskjolds Vag 42 S-75237 Uppsala Sweden;

European Med Agcy London England;

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原文格式 PDF
正文语种 eng
中图分类眼科学;
关键词
regulatory; clinical research; biomarker; validation; drug development;

机译：监管;临床研究;生物标志物;验证;药物开发;

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专利

1. Biomarkers and Surrogate Endpoints in Drug Development: A European Regulatory View [J] . Kerstin Wickstr??m, Jane Moseley Investigative ophthalmology & visual science . 2017,第6期

机译：药物开发中的生物标志物和替代终点：欧洲法规观点
2. Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies. [J] . Lesko LJ, Atkinson AJ Jr Annual Review of Pharmacology and Toxicology . 2001,第0期

机译：在药物开发和监管决策中使用生物标志物和替代终点：标准，验证，策略。
3. Overview of Biomarkers and Surrogate Endpoints in Drug Development [J] . John A.Wagner Disease markers . 2002,第2期

机译：药物开发中的生物标志物和替代终点概述
4. REVIEW OF RECENT DEVELOPMENTS IN EUROPEAN REGULATORY FIRE TEST AND CLASSIFICATION FOR CONSTRUCTION PRODUCTS, ELECTRIC CABLES AND RAILWAYS [C] . Stephen J Grayson, Sean Gregoryb, Suresh Kumara International conference on fire and materials . 2011

机译：回顾欧洲法规防火测试的最新进展以及建筑产品，电缆和铁路的分类
5. Integrated Analysis of Dynamic PET and MR Brain Images for the Development of Imaging Biomarkers of Drug Delivery [D] . Krokos, Georgios. 2018

机译：动态宠物和MR脑形象综合分析，用于发育药物递送的成像生物标志物
6. Overview of Biomarkers and Surrogate Endpoints in Drug Development [O] . John A. Wagner 2002

机译：药物开发中的生物标志物和替代终点概述
7. Overview of Biomarkers and Surrogate Endpoints in Drug Development [O] . John A. Wagner 2002

机译：生物标志物概述和药物开发中的替代终点
8. Conference Summary on Roundtable for the Development of Drugs and Vaccines against Acquired Immuno Deficiency Syndrome (AIDS) Held in Washington, DC on 11-12 September 1989: Surrogate Endpoints in Evaluating the Effectiveness of Drugs against HIV Infectio [R] . Weiss, R., Mazade, L. 1990

机译：1989年9月11日至12日在华盛顿特区举行的针对获得性免疫缺陷综合症（艾滋病）药物和疫苗发展圆桌会议的会议纪要：评估艾滋病毒感染药物有效性的替代终点

Biomarkers and Surrogate Endpoints in Drug Development: A European Regulatory View

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