NEED n 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 n The bioanalytical laboratory demonstrated that this was an additional metabolite, not observed in previous studies APPROACH n Optimized the chromatographic method to solve the tailing, separated the additional metabolite and revalidated the LC-MS/MS method n 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 n The client was able to document the difference in metabolism of different subject p

Join for free to read