Predicting Regulatory Product Approvals Using a Proposed Quantitative Version of FDA’s Benefit–Risk Framework to Calculate Net-Benefit Score and Benefit–Risk Ratio

被引：0
|
作者：
Stephen Sun
Suzanne Heske
Melanie Mercadel
Jean Wimmer
机构：
[1] Syneos Health,
来源：
Therapeutic Innovation & Regulatory Science | 2021年 / 55卷
关键词：
FDA; Benefit–risk framework; Net-benefit; Scoring; Risk management;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
引用
收藏
页码：129 / 137
页数：8
相关论文
共 20 条
  • [1] Predicting Regulatory Product Approvals Using a Proposed Quantitative Version of FDA's Benefit-Risk Framework to Calculate Net-Benefit Score and Benefit-Risk Ratio
    Sun, Stephen
    Heske, Suzanne
    Mercadel, Melanie
    Wimmer, Jean
    [J]. THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2021, 55 (01) : 129 - 137
  • [2] FDA’s Benefit–Risk Framework for Human Drugs and Biologics: Role in Benefit–Risk Assessment and Analysis of Use for Drug Approvals
    Leila Lackey
    Graham Thompson
    Sara Eggers
    [J]. Therapeutic Innovation & Regulatory Science, 2021, 55 : 170 - 179
  • [3] FDA's Benefit-Risk Framework for Human Drugs and Biologics: Role in Benefit-Risk Assessment and Analysis of Use for Drug Approvals
    Lackey, Leila
    Thompson, Graham
    Eggers, Sara
    [J]. THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2021, 55 (01) : 170 - 179
  • [4] Regulatory benefit-risk assessment of oncology drugs: A systematic review of FDA and EMA approvals
    Pinto, Cathy Anne
    Balantac, Zaneta
    Mt-Isa, Shahrul
    Liu, Xinyue
    Bracco, Oswaldo L.
    Clarke, Harrison
    Tervonen, Tommi
    [J]. DRUG DISCOVERY TODAY, 2023, 28 (10)
  • [5] Regulatory benefit-risk assessment of oncology drugs: A systematic review of FDA and EMA approvals
    Tervonen, Tommi
    Pinto, Cathy Anne
    Dudek, Maria E.
    Mt-Isa, Shahrul
    Liu, Xinyue
    Bracco, Oswaldo
    Balantac, Zaneta
    Clarke, Harrison
    [J]. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2022, 31 : 135 - 135
  • [6] A quantitative evaluation of the regulatory assessment of the benefits and risks of rofecoxib relative to naproxen: an application of the incremental net-benefit framework
    Lynd, Larry D.
    Marra, Carlo A.
    Najafzadeh, Mehdi
    Sadatsafavi, Mohsen
    [J]. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2010, 19 (11) : 1172 - 1180
  • [7] Using the Incremental Net Benefit Framework for Quantitative Benefit-Risk Analysis in Regulatory Decision-Making-A Case Study of Alosetron in Irritable Bowel Syndrome
    Lynd, Larry D.
    Najafzadeh, Mehdi
    Colley, Lindsey
    Byrne, Michael F.
    Willan, Andrew R.
    Sculpher, Mark J.
    Johnson, F. Reed
    Hauber, A. Brett
    [J]. VALUE IN HEALTH, 2010, 13 (04) : 411 - 417
  • [8] Comparative Assessment of Clinical Benefit Using the ESMO-Magnitude of Clinical Benefit Scale Version 1.1 and the ASCO Value Framework Net Health Benefit Score
    Cherny, Nathan I.
    de Vries, Elisabeth G. E.
    Dafni, Urania
    Garrett-Mayer, Elizabeth
    McKernin, Shannon E.
    Piccart, Martine
    Latino, Nicola J.
    Douillard, Jean-Yves
    Schnipper, Lowell E.
    Somerfield, Mark R.
    Bogaerts, Jan
    Karlis, Dimitris
    Zygoura, Panagiota
    Vervita, Katerina
    Pentheroudakis, George
    Tabernero, Josep
    Zielinski, Christoph
    Wollins, Dana S.
    Schilsky, Richard L.
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2019, 37 (04) : 336 - +
  • [9] A Quantitative Benefit-Risk Analysis of Isoniazid for Treatment of Latent Tuberculosis Infection Using Incremental Benefit Framework
    Sadatsafavi, Mohsen
    Marra, Carlo
    Marra, Fawziah
    Moran, Onofre
    FitzGerald, J. Mark
    Lynd, Larry
    [J]. VALUE IN HEALTH, 2013, 16 (01) : 66 - 75
  • [10] The FDA's Risk/Benefit Calculus in the Approvals of Qsymia and Belviq: Treating an Obesity Epidemic While Avoiding Another Fen-Phen
    Azebu, Lauren M.
    [J]. FOOD AND DRUG LAW JOURNAL, 2014, 69 (01) : 87 - 111
12