Applying Decision Analysis to Inform the US Food and Drug Administration's Benefit-Risk Assessment of Ticagrelor for Primary Prevention of Myocardial Infarction or Stroke Based on THEMIS

被引:11
|
作者
Lackey, Leila G. [1 ]
Garnett, Christine E. [2 ]
Senatore, Fred [2 ]
机构
[1] Food & Drug Adm, Decis Support & Anal Staff, Off Program & Strateg Anal Off Special Programs, Ctr Drug Evaluat & Res, Silver Spring, MD USA
[2] Food & Drug Adm, Div Cardiol & Nephrol, Off Cardiol Hematol Endocrinol & Nephrol, Off New Drugs Ctr Drug Evaluat & Res, Silver Spring, MD USA
关键词
D O I
10.1161/CIRCULATIONAHA.120.053294
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
[No abstract available]
引用
收藏
页码:655 / 658
页数:4
相关论文
共 11 条
  • [1] Benefit-risk assessment for brincidofovir for the treatment of smallpox: US Food and Drug Administration's Evaluation
    Chan-Tack, Kirk
    Harrington, Patrick
    Bensman, Timothy
    Choi, Su-Young
    Donaldson, Eric
    O'Rear, Julian
    McMillan, David
    Myers, Laine
    Seaton, Mark
    Ghantous, Hanan
    Cao, Yu
    Valappil, Thamban
    Birnkrant, Debra
    Struble, Kimberly
    ANTIVIRAL RESEARCH, 2021, 195
  • [2] Applying Multiple Criteria Decision Analysis to Comparative Benefit-Risk Assessment: Choosing among Statins in Primary Prevention
    Tervonen, Tommi
    Naci, Huseyin
    van Valkenhoef, Gert
    Ades, Anthony E.
    Angelis, Aris
    Hillege, Hans L.
    Postmus, Douwe
    MEDICAL DECISION MAKING, 2015, 35 (07) : 859 - 871
  • [3] Food and Drug Administration Analysis of Ticagrelor Using Data From an Enriched Trial to Evaluate Benefit-Risk Difference in an Unstudied Population
    McDowell, Tzu-Yun
    Blank, Melanie
    Lawrence, John
    Stockbridge, Norman
    CIRCULATION, 2016, 134 (19) : 1500 - 1502
  • [4] Analysis of Benefit-risk Balance in Decision-making of the Food and Drug Administration for Premarket Approval of Therapeutic Medical Devices
    Muragaki, Yoshihiro
    Uematsu, Miyuki
    Iseki, Hiroshi
    Umezu, Mitsuo
    ADVANCED BIOMEDICAL ENGINEERING, 2013, 2 : 101 - 106
  • [5] Benefit-Risk Assessment of Chinese Medicine Injections for Primary Liver Cancer Based on Multi-criteria Decision Analysis
    ZHANG Rongrong
    SHAO Mingyi
    FU Yu
    ZHAO Ruixia
    WANG Jingwen
    FANG Yuxuan
    Chinese Journal of Integrative Medicine, 2024, 30 (06) : 559 - 564
  • [6] Benefit-Risk Assessment of Chinese Medicine Injections for Primary Liver Cancer Based on Multi-criteria Decision Analysis
    Zhang, Rong-rong
    Shao, Ming-yi
    Fu, Yu
    Zhao, Rui-xia
    Wnag, Jing-wen
    Fang, Yu-xuan
    CHINESE JOURNAL OF INTEGRATIVE MEDICINE, 2024, 30 (06) : 559 - 564
  • [7] Benefit-Risk Assessment of Chinese Medicine Injections for Primary Liver Cancer Based on Multi-criteria Decision Analysis
    ZHANG Rongrong
    SHAO Mingyi
    FU Yu
    ZHAO Ruixia
    WANG Jingwen
    FANG Yuxuan
    Chinese Journal of Integrative Medicine, 2024, (06) : 559 - 564
  • [8] US Food and Drug Administration Benefit-Risk Assessment of Nilotinib Treatment Discontinuation in Patients with Chronic Phase Chronic Myeloid Leukemia in a Sustained Molecular Remission
    Pulte, E. Dianne
    Wroblewski, Tanya
    Bloomquist, Erik
    Tang, Shenghui
    Farrell, Ann
    Deisseroth, Albert
    McKee, Amy E.
    Pazdur, Richard
    ONCOLOGIST, 2019, 24 (05): : E188 - E195
  • [9] Benefit-risk assessment for sofosbuvir/velpatasvir/voxilaprevir based on patient population and hepatitis C virus genotype: U. S. Food and Drug Administration's evaluation
    Struble, Kimberly
    Chan-Tack, Kirk
    Qi, Karen
    Naeger, Lisa K.
    Birnkrant, Debra
    HEPATOLOGY, 2018, 67 (02) : 482 - 491
  • [10] The US Food and Drug Administration Risk Assessment on Lead in Women's and Children's Vitamins Is Based on Outdated Assumptions
    Miodovnik, Amir
    Landrigan, Philip J.
    ENVIRONMENTAL HEALTH PERSPECTIVES, 2009, 117 (07) : 1021 - 1022