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