Recommendations for benefit-risk assessment methodologies and visual representations

Hughes Diana; Waddingham Ed; Mt-Isa Shahrul; Goginsky Alesia; Chan Edmond; Downey Gerald F.; Hallgreen Christine E.; Hockley Kimberley S.; Juhaeri Juhaeri; Lieftucht Alfons; Metcalf Marilyn A.; Noel Rebecca A.; Phillips Lawrence D.; Ashby Deborah; Micaleff Alain

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Recommendations for benefit-risk assessment methodologies and visual representations

机译：有利风险评估方法和视觉表现的建议

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PurposeThe purpose of this study is to draw on the practical experience from the PROTECT BR case studies and make recommendations regarding the application of a number of methodologies and visual representations for benefit-risk assessment.

机译：本研究的目的的目的是借鉴保护BR案例研究的实践经验，并提出有关申请许多方法和受益风险评估的视觉表现的建议。

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来源
《Pharmacoepidemiology and drug safety》 |2016年第3期|共12页
作者
Hughes Diana; Waddingham Ed; Mt-Isa Shahrul; Goginsky Alesia; Chan Edmond; Downey Gerald F.; Hallgreen Christine E.; Hockley Kimberley S.; Juhaeri Juhaeri; Lieftucht Alfons; Metcalf Marilyn A.; Noel Rebecca A.; Phillips Lawrence D.; Ashby Deborah; Micaleff Alain;
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作者单位

Pfizer Worldwide Safety Strategy New York NY USA;

Univ London Imperial Coll Sci Technol &

Med Imperial Clin Trials Unit Stadium House London W12;

Univ London Imperial Coll Sci Technol &

Med Imperial Clin Trials Unit Stadium House London W12;

Pfizer New York NY USA;

Johnson &

Johnson Global Med Org Div Janssen Cilag Ltd High Wycombe Bucks England;

Amgen Ltd Cambridge England;

Univ London Imperial Coll Sci Technol &

Med Imperial Clin Trials Unit Stadium House London W12;

Univ London Imperial Coll Sci Technol &

Med Imperial Clin Trials Unit Stadium House London W12;

Sanofi Global Pharmacovigilance &

Epidemiol Pharmacoepidemiol Bridgewater NJ USA;

GlaxoSmithKline UK Ltd RD Chief Med Off Benefit Risk Evaluat Uxbridge Middx England;

GSK US Safety Mgmt RD Chief Med Off Benefit Risk Evaluat Raleigh NC USA;

Eli Lilly &

Co Lilly Corp Ctr Benefit Risk Assessment Indianapolis IN 46285 USA;

London Sch Econ Dept Management London WC2A 2AE England;

Univ London Imperial Coll Sci Technol &

Med Imperial Clin Trials Unit Stadium House London W12;

MerckSerono SA Geneva Switzerland;

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原文格式 PDF
正文语种 eng
中图分类药学;
关键词
benefit-risk; decision-making; drug development; pharmacoepidemiology; regulation;

机译：受益风险;决策;药物开发;药物缺口学;规定;

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专利

1. Recommendations for benefit-risk assessment methodologies and visual representations [J] . Hughes Diana, Waddingham Ed, Mt-Isa Shahrul, Pharmacoepidemiology and drug safety . 2016,第3期

机译：利益风险评估方法和视觉表示的建议
2. Literature review of visual representation of the results of benefit-risk assessments of medicinal products [J] . Hallgreen Christine E., Mt-Isa Shahrul, Lieftucht Alfons, Pharmacoepidemiology and drug safety . 2016,第3期

机译：医药产品利益风险评估结果的视觉表示形式的文献综述
3. Literature review of visual representation of the results of benefit-risk assessments of medicinal products [J] . Hallgreen Christine E., Mt-Isa Shahrul, Lieftucht Alfons, Pharmacoepidemiology and drug safety . 2016,第3期

机译：医药产品受益风险评估结果的视觉表征文献综述
4. Assessments and Eye Movements Compared between Photographs and Visualizations of Logged Forest Vistas - For What Kind of Assessments are Visualisations a Good Representation of Photographs? [C] . Johan PIHEL, Asa ODE SANG, Caroline HAGERHALL, Conference on Digital Landscape Architecture . 2014

机译：评估和眼部运动与登录林VISTAS的照片和可视化之间的评估和眼动 - 对于什么样的评估是易于评估的照片良好的照片？
5. Using high performance computing and visualization to enhance risk assessment methodology: Case study with perchlorate. [D] . Albers, Eric Peter. 2004

机译：使用高性能计算和可视化来增强风险评估方法：高氯酸盐案例研究。
6. Population-based assessment of prevalence and causes of visual impairment in the state of Telangana India: a cross-sectional study using the Rapid Assessment of Visual Impairment (RAVI) methodology [O] . Srinivas Marmamula, Rohit C Khanna, Eswararao Kunkunu, 2016

机译：印度特兰甘纳邦基于人群的视力患病率和原因评估：使用视力障碍快速评估（RAVI）方法进行的横断面研究
7. Recommendations for benefit-risk assessment methodologies and visual representations. [O] . Hughes D, Waddingham E, Mt-Isa S, 2015

机译：关于福利风险评估方法和视觉表示的建议。
8. Performance Assessment Methodology for Low-level Radioactive Waste DisposalFacilitites. Recommendations of NRC's Performance Assessment Working Group [R] . Bradbury, J. W., Cady, R. E., Campbell, C., 2000

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Recommendations for benefit-risk assessment methodologies and visual representations

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