Rethinking the Clinically Based Thresholds of TransCelerate BioPharma for Risk-Based Monitoring

被引：0
|
作者：
Richard C. Zink
Anastasia Dmitrienko
Alex Dmitrienko
机构：
[1] SAS Institute Inc,JMP Life Sciences
[2] University of North Carolina at Chapel Hill,Department of Biostatistics
[3] Columbia University,Data Management and Statistics
[4] Mediana Inc,undefined
[5] Target PharmaSolutions,undefined
来源：
Therapeutic Innovation & Regulatory Science | 2018年 / 52卷
关键词：
Data visualization; exposure-adjusted; risk-based approaches; statistical monitoring; time windows;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
引用
收藏
页码：560 / 571
页数：11
相关论文
共 50 条
  • [31] A risk-based approach to set priorities for wildlife effects monitoring
    Griffin, BJ
    Melton, DA
    Robinson, R
    Davis, LM
    MINING IN THE ARCTIC, 1999, : 91 - 97
  • [32] Risk-Based Monitoring in Clinical Trials: Past, Present, and Future
    Brian Barnes
    Nicole Stansbury
    Debby Brown
    Lauren Garson
    Geoff Gerard
    Nickolas Piccoli
    Debra Jendrasek
    Nick May
    Vanesa Castillo
    Anina Adelfio
    Nycole Ramirez
    Andrea McSweeney
    Ruth Berlien
    Paula Jo Butler
    Therapeutic Innovation & Regulatory Science, 2021, 55 : 899 - 906
  • [33] A Risk-Based Sampling Plan for Monitoring of Histamine in Fish Products
    Guillier, L.
    Thebault, A.
    Gauchard, F.
    Pommepuy, M.
    Guignard, A.
    Malle, P.
    JOURNAL OF FOOD PROTECTION, 2011, 74 (02) : 302 - 310
  • [34] Clinical Research Coordinators' Attitude Toward Risk-Based Monitoring
    Jeong, Ihn Sook
    Jeong, Jeong Hee
    Hwang, Youn Sun
    Youn, Ji Hyang
    THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2019, 53 (05) : 691 - 695
  • [35] Risk-Based Monitoring in Clinical Trials: Past, Present, and Future
    Barnes, Brian
    Stansbury, Nicole
    Brown, Debby
    Garson, Lauren
    Gerard, Geoff
    Piccoli, Nickolas
    Jendrasek, Debra
    May, Nick
    Castillo, Vanesa
    Adelfio, Anina
    Ramirez, Nycole
    McSweeney, Andrea
    Berlien, Ruth
    Butler, Paula Jo
    THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2021, 55 (04) : 899 - 906
  • [36] DRAI: a risk-based drought monitoring and alerting system in Brazil
    Bravo, Raissa Zurli Bittencourt
    Leiras, Adriana
    Oliveira, Fernando Luiz Cyrino
    Cunha, Ana Paula Martins do Amaral
    NATURAL HAZARDS, 2023, 117 (01) : 113 - 142
  • [37] A risk-based approach to monitoring elemental impurities in leachable studies
    Kelly, Kathleen
    Lewen, Nancy
    Pharmaceutical Technology, 2013, 37 (10) : 82 - 84
  • [38] Feasibility of online risk-based monitoring by patients: the Natalizumab case
    Van Noort, E. M. J.
    Kasteleyn, M. J.
    Jongen, P. J. H.
    Veen, H. C. C. M. In't
    Chavannes, N. H.
    MULTIPLE SCLEROSIS JOURNAL, 2017, 23 : 925 - 926
  • [39] A probabilistic risk-based decision framework for structural health monitoring
    Hughes, A.J.
    Barthorpe, R.J.
    Dervilis, N.
    Farrar, C.R.
    Worden, K.
    Mechanical Systems and Signal Processing, 2021, 150
  • [40] Risk-Based Monitoring (RBM) Implementation: Challenges and Potential Solutions
    Nimita Limaye
    Veena Jaguste
    Therapeutic Innovation & Regulatory Science, 2019, 53 : 183 - 189
12345