A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays

被引：3

作者：

Cowan, Kyra J. ^{[1
]}

Kunz, Ulrich ^{[2
]}

Blattmann, Peter ^{[3
]}

Gulati, Pratiksha ^{[4
]}

Hughes, Richard ^{[5
]}

Andersen, Lene ^{[6
]}

Goodman, Joanne ^{[7
]}

Lambert, Frazer ^{[8
]}

Lawrence, James ^{[9
]}

Thwaites, Daniel ^{[10
]}

Golob, Michaela ^{[11
]}

Nelson, Robert ^{[12
]}

Timmerman, Philip ^{[13
]}

机构：

[1] Merck KGaA, Res & Dev, Drug Metab & Pharmacokinet New Biol Entities, D-64293 Darmstadt, Germany

[2] Nuvisan GmbH, Bioanal, D-89231 Neu Ulm, Germany

[3] BioAgilytix Labs, DE-22339 Hamburg, Germany

[4] Novo Nord A S, Clinical LCMS Bioanal, DK-2760 Malov, Denmark

[5] Idorsia Pharmaceut Ltd, Translat Sci, CH-4123 Allschwil, Switzerland

[6] Celerion, Bioanalyt Serv, Lincoln, NE 68502 USA

[7] F Hoffmann La Roche Ltd, Bioanal & Biomarkers Chapter, Pharmaceut Sci, CH-4070 Basel, Switzerland

[8] Resolian Bioanalyt, Newmarket Rd, Fordham CB7 5WW, England

[9] Boehringer Ingelheim Pharm GmbH & Co KG, Translat Med & Clin Pharmacol, D-88400 Biberach An Der Riss, Germany

[10] Charles River Labs, Immunol Bioanal & Biomarkers, Edinburgh EH33 2NE, Scotland

[11] Invox Pharm, Translat Sci, Cambridge CB21 6AD, England

[12] LabCorp Drug Dev, LabCorp Drug Dev Immunol & Immunotoxicol, Harrogate HG3 1PY, England

[13] European Bioanal Forum Vzw EBF, Havenlaan 86c B204, B-1000 Brussels, Belgium

来源：

BIOANALYSIS | 2024年 / 16卷 / 16期

关键词：

biomarkers; Biomarker assay validation; context-of-use statement; regulatory guidance;

D O I：

10.1080/17576180.2024.2376436

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

The European Bioanalysis Forum, alongside key industry stakeholders, has been driving the discussions around the implementation of context-of use for biomarker assays to ensure that these assays are validated appropriately depending on their purpose. Insights into understanding why the implementation of context-of-use in assay strategies has also shown that the key stakeholder, or requester for the biomarker data, is responsible for providing the context-of-use statement for all biomarker assay requests. Experts from across the industry haves repeatedly sought a cross-industry recommended format in which the context-of-use statement could be provided. In this manuscript, the European Bioanalysis Forum suggests a format for this.

引用

页码：835 / 842

页数：8

共 18 条

[1] 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
[2] Update to the European Bioanalysis Forum recommendation on biomarkers assays; bringing context of use into practice
Goodman, Joanne
Cowan, Kyra J.
Golob, Michaela
Karlsson, Lars
Kunz, Ulrich
Nelson, Robert
Ulrichts, Hans
Stevenson, Lauren
Terry, Linda
Timmerman, Philip
BIOANALYSIS, 2020, 12 (20) : 1427 - 1437
[3] European Bioanalysis Forum recommendation on biomarker bioanalysis published in Bioanalysis
Timmerman, Philip
BIOANALYSIS, 2012, 4 (15) : 1839 - 1839
[4] European Bioanalysis Forum recommendation on biomarker bioanalysis published in Bioanalysis
Timmerman, Philip
BIOMARKERS IN MEDICINE, 2012, 6 (04) : 509 - 509
[5] Applying context of use to quantitative polymerase chain reaction method validation and analysis: a recommendation from the European Bioanalysis Forum
Lauren, Anna
Braun, Manuela
Byrne, Paul
Cazzin, Chiara
Colletti, Kelly
Cox, Chris
Dietz, Lisa
Emrich, Thomas
Geddes, Kristin
Herr, Kate
Iles, Tracy
Rogue, Alexandra
Verlinden, Yvan
Timmerman, Philip
BIOANALYSIS, 2021, 13 (23) : 1723 - 1729
[6] Tiered approach into practice: scientific validation for chromatography-based assays in early development - a recommendation from the European Bioanalysis Forum
Timmerman, Philip
White, Stephen
McDougall, Stuart
Kall, Morten A.
Smeraglia, John
Fjording, Marianne Scheel
Knutsson, Magnus
BIOANALYSIS, 2015, 7 (18) : 2387 - 2398
[7] European Bioanalysis Forum recommendation on method establishment and bioanalysis of biomarkers in support of drug development
Timmerman, Philip
Herling, Christian
Stoellner, Daniela
Jaitner, Birgit
Pihl, Susanne
Elsby, Karen
Henderson, Neil
Barroso, Begona
Fischmann, Stephanie
Companjen, Arjen
Versteilen, Amanda
Bates, Stewart
Kingsley, Clare
Kunz, Ulrich
BIOANALYSIS, 2012, 4 (15) : 1883 - 1894
[8] Exploratory biomarker assays: key assay parameters to evaluate in the face of evolving biomarker context-of-use
Thankamony, Sai P.
Zhang, Yan
BIOANALYSIS, 2019, 11 (23) : 2095 - 2097
[9] European Bioanalysis Forum recommendation: scientific validation of quantification by accelerator mass spectrometry
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Young, Graeme
Timmerman, Philip
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BIOANALYSIS, 2012, 4 (22) : 2669 - 2679
[10] 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

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