Assessment of Risk Evaluation and Mitigation Strategies (REMS) for varenicline (Chantix): A multistage patient survey

Amend Kandace L.; Younus Muhammad; Petronis Kenneth R.; Mo Jingping; Seeger John D.; Gately Robert; Gu Xiangmei; Enger Cheryl

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Assessment of Risk Evaluation and Mitigation Strategies (REMS) for varenicline (Chantix): A multistage patient survey

机译：瓦宁林风险评估和缓解策略评估（Chantix）：多级患者调查

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PurposeTo evaluate the Risk Evaluation and Mitigation Strategies (REMS) for varenicline by assessing patients' understanding of the varenicline medication guide (MG) at pre-specified time points: 18months, 3years, and 7years after the REMS approval.

机译：Purposeto通过评估预先指定时间点的患者对患者的患者的理解评估患者的风险评估和缓解策略（REMS）：18个月，3年，7年后，REMS批准后7年。

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来源
《Pharmacoepidemiology and drug safety》 |2018年第3期|共10页
作者
Amend Kandace L.; Younus Muhammad; Petronis Kenneth R.; Mo Jingping; Seeger John D.; Gately Robert; Gu Xiangmei; Enger Cheryl;
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作者单位

Optum Epidemiol Boston MA USA;

Pfizer Inc Worldwide Safety &

Regulatory Epidemiol New York NY USA;

Pfizer Inc Worldwide Safety &

Regulatory Epidemiol New York NY USA;

Pfizer Inc Worldwide Safety &

Regulatory Epidemiol New York NY USA;

Optum Epidemiol Boston MA USA;

Optum Epidemiol Boston MA USA;

Optum Epidemiol Boston MA USA;

Optum Epidemiol Boston MA USA;

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原文格式 PDF
正文语种 eng
中图分类药学;
关键词
medication guide; pharmacoepidemiology; REMS; risk management; risk mitigation evaluation; smoking cessation; survey; varenicline;

机译：药物指南;药物缺口学;REMS;风险管理;风险缓解评估;戒烟;调查;varenicline;

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专利

1. Assessment of Risk Evaluation and Mitigation Strategies (REMS) for varenicline (Chantix): A multistage patient survey [J] . Amend Kandace L., Younus Muhammad, Petronis Kenneth R., Pharmacoepidemiology and drug safety . 2018,第3期

机译：瓦宁林风险评估和缓解策略评估（Chantix）：多级患者调查
2. Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications—Guidance for Industry [J] . Biotechnology Law Report . 2009,第6期

机译：建议的风险评估和缓解策略（REMS），REMS评估以及REMS修改建议的格式和内容—行业指南
3. The US Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) program in practice: Does it really inform patients and limit risk? [J] . CohenR.A., BrownR.S. American Journal of Kidney Diseases: The official journal of the National Kidney Foundation . 2012,第5期

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4. A Survey on the Impact of Risk Factors and Mitigation Strategies in Global Software Development [C] . Saad Yasser Chadli, Ali Idri World Conference on Information Systems and Technologies . 2018

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5. Effect of Risk Evaluation and Mitigation Strategies (REMS) on utilization of thiazolidinediones in a Medicaid population. [D] . Mendonca, Clive M. 2015

机译：风险评估和缓解策略（REMS）对医疗补助人群中噻唑烷二酮利用的影响。
6. Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014–2018) [O] . Linda Huynh, Gita A. Toyserkani, Elaine H. Morrato 2021

机译：实施科学框架对监管科学的务实应用：对FDA风险评估和缓解策略的评估（REMS）（2014-2018）
7. PRS40 THE IMPACT OF THE FDA'S RISK EVALUATION AND MITIGATION STRATEGIES (REMS) INITIATIVE ON PRESCRIPTION PATTERN FOR DRUGS APPROVED UNDER THE REMS PROGRAM AND RELEVANT NON-REMS COMPETITORS [O] . Horowicz-Mehler N, Sepulveda B, White C, 2010

机译：PRS40 FDA风险评估和缓解策略（REMS）对REMS计划和相关的非REMS竞争对手批准的药物处方类型的影响
8. Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS) [R] . 2014

机译：标准化和评估风险评估和缓解策略（REms）

Assessment of Risk Evaluation and Mitigation Strategies (REMS) for varenicline (Chantix): A multistage patient survey

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