Original Publication Date: 6 November, 2018
Publication / Source: Bioanalysis 10(21)
Authors: Kall MA, Michi M, van der Strate B, Freisleben A et al.
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?
Incurred sample reanalysis (ISR) was, in its current form, introduced at