Thermo Fisher Scientific has introduced an Incurred Sample Reanalysis (ISR) Information Kit, a vendor-neutral guide designed to educate pharmaceutical scientists on using the technique to assess the quality of bioanalytical methods effectively. It contains up-to-date information on changing regulatory guidance, including the official US Food and Drug Administration CDER bioanalytical method validation guidance paper, the latest Crystal City workshop report and a selection of papers from the AAPS Journal exploring ISR methods and best practices. This comprehensive kit provides scientists with the information required to establish a robust ISR program and is available to download from www.thermoscientific.com/isr.
ISR was recently established as a viable method for re-analysing samples obtained from in-vivo studies in order to test the reproducibility of bioanalytical methods. To facilitate efficient use of the ISR method, pharmaceutical companies and contract research organisations need detailed guidance. Thermo Fisher developed this new kit to provide thorough direction for ISR assessment, studies that should be conducted, the selection of samples, acceptance criteria and reporting of results. During drug development, bioanalytical methods are validated and used to quantify drugs and their metabolites in a variety of biological matrices.
In response to industry requirements for dependable laboratory information management systems (LIMS) that incorporate ISR capabilities as standard, Thermo Fisher offers a comprehensive solution for ISR, which includes Thermo Scientific Watson LIMS 7.4 software integrated with the TSQ series mass spectrometers. The data processing and reporting features of the LIMS have been substantially improved, yielding better functionality and greater ease-of-use. Watson LIMS is now capable of accommodating the ISR samples within the same run as the regular bioanalytical samples.