Incurred sample reproducibility: 10 years of experiences: views and recommendations from the European Bioanalysis Forum. (6th November 2018)

• Record Type: Journal Article
• Authors: Kall, Morten Anders; Michi, Marco; van der Strate, Barry; Freisleben, Achim; Stoellner, Daniela; Timmerman, Philip
• Is Part Of: Bioanalysis. Volume 10:Number 21(2018)
• Page Start: 1723
• Page End: 1732
• Publication Date: 2018-11-06
• Subjects: European Bioanalysis Forum -- incurred sample reanalysis -- incurredsample reproducibility; Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio-2018-0194
• Languages: English
• ISSNs: 1757-6180

Abstract

With 10 years of experiences on incurred sample reanalysis (ISR) as an integrated part of regulated bioanalysis, the European Bioanalysis Forum has reflected on the implementation and the use of ISR. Three surveys were conducted in 2016 and 2017 as a revisit of the ISR experiences within European pharmaceutical industry and contract research organizations: has ISR become a tool for postvalidation and process check of a bioanalytical method performance and has ISR become a routine in our laboratories? Do we agree on the interpretation of guidelines/guidance and are we aligned in our approach – among others?