Optimized LC-MS/MS Method for New Observed Metabolite
Scientific Expertise
Problem Solving
Need
For multiple European clinical studies, the generated samples were analyzed using a validated LC-MS/MS method. During sample analysis of a non-European clinical study an unexpected shouldering of the known metabolite peak was observed
The bioanalytical laboratory demonstrated that this was an additional metabolite, not observed in previous studies
Approach
Optimized the chromatographic method to solve the tailing, separated the additional metabolite and revalidated the LC-MS/MS method
Reanalyzed a percentage of study samples generated in previous European clinical studies to demonstrate the additional metabolite was specific to a non-European population
Benefits
The client was able to document the difference in metabolism of different subject populations at the beginning of the drug development process
