This vendor-neutral ISR guide is designed to educate pharmaceutical scientists on using the technique to effectively assess the quality of bioanalytical methods. 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-analyzing 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 organizations 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 superior 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, the most commonly used bioanalytical data system in the pharmaceutical industry, is now capable of accommodating the ISR samples within the same run as the regular bioanalytical samples.