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Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risksof Pharmaceutical Products. Workshop Summary. Held in White Oak, Maryland on February 12, 2014 and May 12, 2014.

机译：在药品利益和风险评估中表征和传播不确定性。研讨会摘要。 2014年2月12日和2014年5月12日在马里兰州的白橡树举行。

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摘要

On February 12 and May 12, 2014, the Institute of Medicine’s (IOM’s) Forum on Drug Discovery, Development, and Translation (the Forum) held public workshops at FDA Headquarters in White Oak, Maryland, to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions on February 12 were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process.

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作者
Caruso, D.; English, R. A.; Claiborne, A. B.;
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年度 2014
页码 1-150
总页数 150
原文格式 PDF
正文语种 eng
中图分类工业技术;
关键词
Pharmaceutical products; Drug safety; Workshops; Benefit assessment; Risk assessment; Drug development; Decision making; Communication; Prescription Drug User Fee Act (PDUFA);

机译：药品;药品安全;研讨会;效益评估;风险评估;药物开发;决策;沟通;处方药用户费法案（pDUFa）;

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6. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products. Workshop Summary. Held in White Oak, Maryland on February 12, 2014 and May 12, 2014. [R] . Caruso, D., English, R. A., Claiborne, A. B. 2014

机译：药品利益和风险评估中的不确定性表征和沟通。研讨会摘要。 2014年2月12日和2014年5月12日在马里兰州的白橡树举行。

Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risksof Pharmaceutical Products. Workshop Summary. Held in White Oak, Maryland on February 12, 2014 and May 12, 2014.

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