title: Blood stability testing: European Bioanalysis Forum view on current challenges for regulated bioanalysis.
abstract: Since 2008, blood stability testing has gained considerable attention in the European Bioanalysis Forum (EBF) with discussions aiming to align processes, timing and reporting of analyte stability testing in blood as part of method development and validation. In this recommendation, EBF summarizes the conclusions reached to date and aims to provide recommendation for the experimental conduct of such assays as well as the inclusion of stability testing into the scope of method development and validation. Besides considering a step-wise approach for blood stability testing, recommendation is made to analyze the blood fraction using a qualified assay in order to circumvent important experimental hurdles. This article will provide an increased understanding of the impact of blood stability testing but furthermore invites scientists to share their views in order to refine the thinking to reach a global harmonized view.
authors.affiliation: Merck Serono, Am Feld 32, D 85567 Grafing. achim.freisleben@merck.de
authors.forename: Achim
authors.initials: A
authors.lastname: Freisleben
authors.forename: Margarete
authors.initials: M
authors.lastname: Brudny-Klöppel
authors.forename: Hans
authors.initials: H
authors.lastname: Mulder
authors.forename: Ronald
authors.initials: R
authors.lastname: de Vries
authors.forename: Marcel
authors.initials: M
authors.lastname: de Zwart
authors.forename: Philip
authors.initials: P
authors.lastname: Timmerman
mesh_terms: D002623:Chemistry Techniques, Analytical / Q000592:standards*; D004355:Drug Stability; D007391:International Cooperation; D004364:Pharmaceutical Preparations / Q000097:blood*; D013048:Specimen Handling / Q000592:standards; D054928:Validation Studies as Topic
chemical_list: D004364:Pharmaceutical Preparations