Challenges of Validating Small Molecule LC-MS/MS Biomarker Methods
Posted on Fri, Jan 20, 2012 @ 09:37 AM
Biomarkers in drug development - The quantification of small molecule exploratory biomarkers can present a significant added challenge over and above that faced for regulated bioanalysis of xenobiotic drugs. With an increase in the use of biomarkers in drug development, limited sample volume and endogenous assay validation, the development of robust high-throughput multianalyte assays has become a regular challenge. Whilst “fit-for-purpose” assay validations are proposed for large molecule biomarker analysis, when and where is this applicable to small molecule LC-MS/MS assays?
Challenges of validating small molecule LC-MS/MS biomarker methods
At the 2011 EBF - Open Symposium, Richard Houghton, Principal Scientist within Bioanalytical Sciences at Quotient Bioresearch presented on Challenges of validating small molecule LC-MS/MS biomarker methods. He described the development of LC-MS/MS methods for the measurement of a number of analytes in human matrix samples and the challenges of validation for use in a regulated bioanalytical arena. This includes the successful application of a surrogate matrix calibration strategy, used routinely at Quotient Bioresearch for the quantification of endogenous analytes.
Download a copy of the presentation to:
- See a summary of a recent GCC survey on biomarker validation strategies
- Learn about the generic approach Quotient applies to the validation of endogenous methods
- Find out about some of the challenges of biomarker validation using a case study
