White Paper – incurred sample reproducibility: 10 years of experience and recommendations from the EBF

Want to stay updated with the latest news and gain exclusive access to Bioanalysis journal articles? Become a member for free. 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...