2,272
Views
0
CrossRef citations to date
0
Altmetric
White Paper

Addressing The Challenges of Biomarker Calibration Standards in Ligand-Binding Assays: A European Bioanalysis Forum Perspective

, , , , , , , , , & show all
Pages 1493-1508 | Received 27 Jun 2017, Accepted 11 Aug 2017, Published online: 21 Oct 2017

References

  • Wild D , SheehanC. Standardization and calibration. In : The Immunoassay Handbook (4th Edition). WildD ( Ed.). Elsevier, Oxford, UK, 315–322 (2013).
  • Sweep FCGJ , FritscheHA, GionMet al. Considerations on development, validation, application and quality control of immuno(metric) biomarker assays in clinical cancer research: an EORTC-NCI working group report. Int. J. Oncol. 23, 1715–1726 (2003).
  • Cull CA , ManleySE, StrattonIMet al. Approach to maintain comparability of biochemical data during long-term clinical trials. Clin. Chem. 43 (10), 1913–1918 (1997).
  • Timmerman P , HerlingC, StoellnerDet al. European Bioanalysis Forum recommendation on method establishment and bioanalysis of biomarkers in support of drug development. Bioanalysis4 (15), 1883–1894 (2012).
  • Jani D , AllinsonJ, BerishaFet al. Recommendations for use and fit-for-purpose validation of biomarker multiplex ligand binding assays in drug development. AAPS J. 18 (1), 1–14 (2016).
  • Bower JF , McClungJB, WatsonCet al. Recommendations and best practices for reference standards and reagents used in bioanalytical method validation. AAPS J. 16 (2), 352–356 (2014).
  • Lee JW . Method validation and application of protein biomarkers: basic similarities and differences from biotherapeutics. Bioanalysis1 (8), 1461–1474 (2009).
  • Lee JW , DevanarayanV, BarrettYCet al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 23 (2), 312–328 (2006).
  • Thway TM , DeSilvaB. Stability assessment in ligand-binding assays: a critical parameter for data integrity. Bioanalysis7 (11), 1315–1317 (2015).
  • Amaravadi L , SongA, MylerHet al. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3 – LBA, biomarkers and immunogenicity). Bioanalysis7 (24), 3107–3124 (2015).
  • Nicholson R , LowersS, CaturlaMCet al. 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars. Bioanalysis4 (19), 2335–2342 (2012).
  • Stevenson LF , PurushothamaS. Parallelism: considerations for the development, validation and implementation of PK and biomarker ligand-binding assays. Bioanalysis6 (2), 185–198 (2014).
  • Wang J , LeeJ, BurnsDet al. “Fit-for-purpose” method validation and application of a biomarker (C-terminal telopeptides of type I collagen) in denosumab clinical studies. AAPS J. 11 (2), 385–394 (2009).
  • Viswaanathan CT , BansalS, BoothBet al. Workshop/conference report – Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 9 (1), E30–E42 (2007).
  • European Medicines Agency, Committee for Medicinal Products for Human Use . Guideline on Bioanalytical Method Validation. London, UK (2011). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf.
  • US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, Center for Veterinary Medicine . Guidance for Industry, Bioanalytical Method Validation. MD, USA (2001). https://www.fda.gov/downloads/Drugs/Guidance/ucm070107.pdf.
  • Algeciras-Schimnich A , BrunsDE, BoydJCet al. Failure of current laboratory protocols to detect lot-to-lot reagent differences: findings and possible solutions. Clin. Chem. 59 (8), 1187–1194 (2013).
  • Timmerman P . Tiered approach revisited: introducing stage-appropriate or assay-appropriate scientific validation. Bioanalysis6 (5), 599–604 (2014).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.