Multi-Species Simultaneous Qualification of Bioanalytical Methods for Compounds at Late Drug Discovery Stage

摘要

A robust bioanalytical qualification procedure has been developed that is capable of supporting analysis of biological samples from five species concurrently. The total method qualification data acquisition time was two weeks, i.e. four fold less compared to that required during a conventional bioanalytical study for the same quality data, which met current accepted work practice guidelines. The new approach provides an alternative method to qualify bioanalytical methods while maintaining scientific rigor and saving time and resources for compounds without major bioanalytical challenges. Applying the qualified method to real samples demonstrated the usefulness of combining multiple species into a single run.