Bioanalysis Zone

Modify on the fly: triple quad to high resolution in support of a dermal clinical study requiring an ultra low LLOQ


Background: FTIH studies can be challenging due to the varying dosing regimens and rapid data delivery. Chemists are asked to provide ultra-low limits of quantitation to provide an understanding of patient efficacy and safety in order to progress drug development. In a recent dermal study it became necessary to reduce the LLOQ of a small molecule drug from 50 to 1 pg/ml due to reductions in the dose and surface area of drug application. Methodology: The 50-fold increase in assay sensitivity necessitated the use of a high-resolution mass spectrometer (LC–HRMS) to separate matrix interferences observed when using a unit resolution triple quadrupole MS. Conclusion: A sensitive, robust assay was validated to support of a FTIH study using a LC–HRMS.

To view restricted content, please:


Leave A Comment

Please wait...

Bioanalysis Zone New Investigator Award

Why not start this year by doing something good by nominating an early career scientist for the Bioanalysis Zone New Investigator Award. Complete the details below to register your interest!