Publication / Source: Bioanalysis 3(9)
Authors: Booth B
“In this issue of Bioanalysis we have focussed on incurred sample reanalysis, with the aim of providing some examples of incurred sample reanalysis failures and ensuing investigations, to provide a greater shared experience.”
Welcome to this edition of Bioanalysis in which we focus on incurred sample reanalysis (ISR). In some sense, ISR sort of popped up out of nowhere in 2006. Although Canadian authorities had been pursuing ISR for some time, they had decided to forego this avenue by 2006. The issue arose up at the AAPS conference in Crystal City, VA, USA. Scientists from industry, academia and government had gathered for the conference on bioanalytical method validation convened by AAPS and the US FDA. The main focus of the conference had been updating issues with chromatographic assays, after some years of experience, and to discuss ligand-binding assays, which had begun to emerge as biological products started to gain approval for use in the marketplace.