- bioanalytical
- incurred sample reproducibility
- industry experience
For more than a decade, incurred sample reproducibility (ISR) has been one the most debated discussions in regulated bioanalysis. By in large, the industry acknowledges the value and importance of ISR to ensure the reproducibility of a newly developed method as a postvalidation experiment when applied for the first-time incurred samples. However, concerns remain about the cost efficiency of the practice. As guest editors, we thought it is time to reflect on ISR application and practice and to bring a few industry opinion leaders together in a special issue of this journal to learn from their experiences and vision on the theme.