Details

Autor(en) / Beteiligte

• Kunz, Ulrich
• Goodman, Joanne
• Loevgren, Ulf
• Piironen, Timo
• Elsby, Karen
• Robinson, Paul
• Pihl, Susanne
• Versteilen, Amanda
• Companjen, Arjen
• Fjording, Marianne Scheel
• Timmerman, Philip

Titel

Addressing the challenges of biomarker calibration standards in ligand-binding assays: a European Bioanalysis Forum perspective

Ist Teil von

• Bioanalysis, 2017-10, Vol.9 (19), p.1493-1508

Ort / Verlag

England: Future Science Ltd

Erscheinungsjahr

2017

Link zum Volltext

Quelle

Taylor & Francis Journals Auto-Holdings Collection

Beschreibungen/Notizen

• The analysis of biomarkers by ligand-binding assays offers significant challenges compared with the bioanalysis of small and large molecule drugs. The presence of endogenous analyte is a commonly cited issue. Also the sourcing and application of appropriate calibration or reference standards can present many issues. One of the main challenges is ensuring the continuity and validity of biomarker data when the source or lot number of calibration standard changes within or between studies. Several strategies exist in attempting to deal with this and standardize the biomarker data through the assay life or looking for ways to compare and normalize biomarker data. In this manuscript, the European Bioanalysis Forum view on dealing with calibration standards in biomarker assays is described.