DBS in Toxicology: “Can Science Overcome the Regulatory Challenge?”
Dried Blood Spot (DBS) analysis can provide significant advantages in drug development as it reduces blood sampling volumes, improves data quality and reduces costs. At the recent Society of Toxicology (SOT) Annual Meeting, Dr. Fabio Garofolo, Vice-President Bioanalytical Services, Algorithme Pharma, presented on DBS analysis and highlighted the Pre-Cut technique for use in analyzing New Molecular Entities (NME) and Biomarkers.
Attendees were provided with three Case Studies demonstrating methods which overcome current DBS issues, such as hematocrit impact, dilution effect, internal standard techniques and stability considerations. With this approach taken, DBS can be used as an effective sampling technique, leading to regulatory agency acceptance.