Kyra J Cowan, Ulrich Kunz, Peter Blattmann, Pratiksha Gulati, Richard Hughes, Lene Andersen, Joanne Goodman, Frazer Lambert, James Lawrence, Daniel Thwaites, Michaela Golob, Robert Nelson, Philip Timmerman
{"title":"欧洲生物分析论坛关于要求提供使用背景说明以成功开发和验证生物标志物检测方法的建议。","authors":"Kyra J Cowan, Ulrich Kunz, Peter Blattmann, Pratiksha Gulati, Richard Hughes, Lene Andersen, Joanne Goodman, Frazer Lambert, James Lawrence, Daniel Thwaites, Michaela Golob, Robert Nelson, Philip Timmerman","doi":"10.1080/17576180.2024.2376436","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9000,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays.\",\"authors\":\"Kyra J Cowan, Ulrich Kunz, Peter Blattmann, Pratiksha Gulati, Richard Hughes, Lene Andersen, Joanne Goodman, Frazer Lambert, James Lawrence, Daniel Thwaites, Michaela Golob, Robert Nelson, Philip Timmerman\",\"doi\":\"10.1080/17576180.2024.2376436\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":8797,\"journal\":{\"name\":\"Bioanalysis\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2024-08-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Bioanalysis\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/17576180.2024.2376436\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"BIOCHEMICAL RESEARCH METHODS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Bioanalysis","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/17576180.2024.2376436","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"BIOCHEMICAL RESEARCH METHODS","Score":null,"Total":0}
A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays.
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.
BioanalysisBIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL
CiteScore
3.30
自引率
16.70%
发文量
88
审稿时长
2 months
期刊介绍：
Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing.
The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality.
Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing.
The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques.
Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
