Feedback from the EBF – Focus Workshop: bringing assay validation and analysis of biomarkers into practice-Reference-Cited by-同舟云学术

Feedback from the EBF – Focus Workshop: bringing assay validation and analysis of biomarkers into practice

Published:2017-05 Issue:9 Volume:9 Page:675-681
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Timmerman Philip¹,Scheel Fjording Marianne²,Allinson John³,Arfvidsson Cecilia⁴,Barroso Begoña⁵,Diczfalusy Ulf⁶,Freeman Adrian⁷,Hickford Elizabeth⁸,Kandousi Hamza⁹,Katugampola Sidath¹⁰,Kunz Ulrich¹¹,Nelson Robert¹²,Smeraglia John⁸

Affiliation:

1. Janssen Research & Development, Turnhoutseweg, 30 B-2340 Beerse, Belgium

2. Novo Nordisk, Måløv, Denmark

3. LGC Group, Fordham, UK

4. AstraZeneca, Gothenburg, Sweden

5. Astellas Europe, Leiden, the Netherlands

6. Karolinska Institutet, Solna, Sweden

7. Envigo, Alconbury, UK (currently employed by LGC)

8. UCB Pharma, Braine, Belgium

9. Bristol Meyer Squib, Princeton, NJ 08540, USA

10. UK Cancer Institute, London EC1V 4AD, UK

11. Boehringer Ingelheim Pharma, Biberach, Germany

12. Novimmune, Geneva, Switzerland

Abstract

European Bioanalysis Forum Focus Workshop, Lisbon, Portugal, 9–10 June 2016 At the recent European Bioanalysis Forum's Focus Workshop ‘Bringing Assay Validation and Analysis of Biomarkers into Practice’, the discussion on best practice for biomarker assay validation continued. Both the presentations and the adjacent panel discussions yielded valuable food for thought for the broader bioanalytical community. The present conference report summarizes the essence from these discussions and from the proposals or conclusions made by all delegates on how to increase the necessary connectivity of the stakeholders involved in the bioanalysis of biomarkers.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

http://www.future-science.com/doi/pdf/10.4155/bio-2017-0045

Reference13 articles.

1. European Bioanalysis Forum recommendation on method establishment and bioanalysis of biomarkers in support of drug development

2. Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance

3. Workshop Report: Crystal City VI—Bioanalytical Method Validation for Biomarkers

Cited by 6 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. A biomarker assay validation approach tailored to the context of use and bioanalytical platform;Bioanalysis;2023-07

2. Target occupancy biomarker assay development using a conformation-selective antibody against small-molecule-bound TNF;Bioanalysis;2023-03

3. Progress with Metabolomic Blood Tests for Gastrointestinal Cancer Diagnosis—An Assessment of Biomarker Translation;Cancer Epidemiology, Biomarkers & Prevention;2022-10-10

4. An industry perspective on the US FDA biomarker qualification effort;Bioanalysis;2018-06-01

5. Parallelism: the foundation of biomarker assay development and validation;Bioanalysis;2018-06-01