Exploratory biomarker assays: key assay parameters to evaluate in the face of evolving biomarker context-of-use

被引：4
|
作者：
Thankamony, Sai P. [1 ]
Zhang, Yan [1 ]
机构：
[1] Bristol Myers Squibb Co, Bioanalyt Sci, Princeton, NJ 08540 USA
来源：
BIOANALYSIS | 2019年 / 11卷 / 23期
关键词：
biomarker; context of use; parallelism; repeatability; specificity; VALIDATION; RECOMMENDATIONS; IMPLEMENTATION;
D O I：
10.4155/bio-2019-0223
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
引用
收藏
页码：2095 / 2097
页数：3
相关论文
共 7 条
  • [1] Biomarker context-of-use: how organizational design can impact the implementation of the appropriate biomarker assay strategy
    Cowan, Kyra J.
    Golob, Michaela
    Goodman, Joanne
    Lauren, Anna
    Andersen, Lene
    De Decker, Philip
    Dejager, Lien
    Fjording, Marianne Scheel
    Groenen, Peter
    Jasnowski, Renaud
    Justies, Nicole
    Kimberg, Matti
    Kunz, Ulrich
    Lawrence, James
    Richter, Mario
    Sorde, Laetitia
    van Trigt, Radboud
    Vermet, Laurent
    Vitaliti, Alessandra
    Wright, Michael
    Timmerman, Philip
    BIOANALYSIS, 2022, 14 (13) : 911 - 917
  • [2] A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays
    Cowan, Kyra J.
    Kunz, Ulrich
    Blattmann, Peter
    Gulati, Pratiksha
    Hughes, Richard
    Andersen, Lene
    Goodman, Joanne
    Lambert, Frazer
    Lawrence, James
    Thwaites, Daniel
    Golob, Michaela
    Nelson, Robert
    Timmerman, Philip
    BIOANALYSIS, 2024, 16 (16) : 835 - 842
  • [3] A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays (Aug, 10.1080/17576180.2024.2376436, 2024)
    Cowan, Kyra J.
    Kunz, Ulrich
    Blattmann, Peter
    Gulati, Pratiksha
    Hughes, Richard
    Andersen, Lene
    Goodman, Joanne
    Lambert, Frazer
    Lawrence, James
    Thwaites, Daniel
    Golob, Michaela
    Nelson, Robert
    Timmerman, Philip
    BIOANALYSIS, 2024, 16 (19-20) : 1093 - 1093
  • [4] Progress regarding the context-of-use of tau as biomarker of Alzheimer's disease and other neurodegenerative diseases
    Campese, Nicole
    Palermo, Giovanni
    Del Gamba, Claudia
    Beatino, Maria Francesca
    Galgani, Alessandro
    Belli, Elisabetta
    Del Prete, Eleonora
    Della Vecchia, Alessandra
    Vergallo, Andrea
    Siciliano, Gabriele
    Ceravolo, Roberto
    Hampel, Harald
    Baldacci, Filippo
    EXPERT REVIEW OF PROTEOMICS, 2021, 18 (01) : 27 - 47
  • [5] A biomarker assay validation approach tailored to the context of use and bioanalytical platform
    Hickford, Elizabeth S.
    Dejager, Lien
    Yuill, Daisy
    Kotian, Apoorva
    Shankar, Sucharita
    Staelens, Ludovicus
    Ulrichts, Hans
    Lewis, Sion
    Louber, Jade
    Williams, Amanda
    Le Provost, Gabrielle S.
    Cutler, Paul
    BIOANALYSIS, 2023, 15 (13) : 757 - 771
  • [6] Biomonitoring of workers employed in a titanium dioxide production plant: Use of buccal micronucleus cytome assay as noninvasive biomarker to evaluate genotoxic and cytotoxic effects
    Ursini, Cinzia Lucia
    Di Basilio, Marco
    Ciervo, Aureliano
    Fresegna, Anna Maria
    Maiello, Raffaele
    Buresti, Giuliana
    Campopiano, Antonella
    Angelosanto, Federica
    Papacchini, Maddalena
    Iavicoli, Sergio
    Cavallo, Delia
    ENVIRONMENTAL AND MOLECULAR MUTAGENESIS, 2021, 62 (04) : 242 - 251
  • [7] Feedback from a workshop by the European Bioanalysis Forum on assay validation requirements for in vitro assays following the publication of ICH M12 guideline - a plea for context-of-use over ICH M10 standards
    Timmerman, Philip
    White, Steve
    Adcock, Neil
    Arfvidsson, Cecilia
    Barfield, Matthew
    Cowan, Kyra
    Ferrari, Luca
    Golob, Michaela
    Goodwin, Lee
    Hughes, Richard
    Ivanova, Tsvetelina
    Lauren, Anna
    Mcdougall, Stuart
    Nelson, Robert
    van de Merbel, Nico
    Verhaeghe, Tom
    Wright, Michael
    BIOANALYSIS, 2025, 17 (06) : 379 - 382
1