Thermo Fisher has introduced an incurred sample reanalysis (ISR) information packet to educate pharmaceutical scientists on using the technique to assess the quality of bioanalytical methods.
This vendor-neutral ISR guide 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 programme.
Thermo Fisher developed the 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 solution for ISR that 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.
The Watson LIMS bioanalytical data system is now capable of accommodating the ISR samples within the same run as the regular bioanalytical samples.
