Publication / Source: Bioanalysis 3(9)
Authors: Garofolo F, Bergeron A, Savoie N
“…our determination to develop a robust, scientifically sound and high-quality method, as well as our employees’ professionalism and our quality system, keep us away from incurred sample reanalysis failures.”
According to the 1992 Health Protection Branch Canadian Guidance, randomly selected 15% incurred samples were required to be reanalyzed as part of bioavailability and bioequivalence studies. However, perhaps due to a lack of acceptance criteria, the Therapeutic Products Directorate of Health Canada revoked this requirement in 2003 and incurred sample reanalysis (ISR) was laid aside for approximately 3 years. In May 2006, at the third AAPS/US FDA Bioanalytical Workshop (Crystal City III), the US FDA stated that the evaluation of ISR needs to be performed as part of both pre-clinical and clinical studies.