Improving ISR Success Rates In Bioanalysis Of Small Molecule Drugs

By Sujata Bhavekar, Bioanalytical Study Director and Principal Investigator, SGS Health Sciences

In order to gather the most reliable and accurate data to support clinical trials and regulatory submissions, drug sponsors must gather robust bioanalytical approaches to ensure precision, accuracy, and reproducibility. To aid this, consider the benefits of leveraging incurred sample reanalysis (ISR), a quality control process in which previously analyzed biological samples are reanalyzed to verify the consistency and reliability of the results. ISR is used to verify the precision of the original analysis and to support regulatory submissions.

When it comes to small molecule production, ISR provides a variety of advantages, including the ability to ensure consistent measurements, keep measurement variability within acceptable limits, and verify that data is consistent with limited amounts of material. Furthermore, it can be used to ensure that interferences from the biological matrix do not affect result accuracy and to provide robust data to support small molecule regulatory submissions. Download the full article to learn more about how ISR can benefit your small molecule workflows.