I'm interested in hearing how folks are approaching interference testing in LC-MS/MS methods for drug-drug interaction studies under the ICH M10 guidance. I see a huge range of possibilities and wonder what approach others are taking. The Options I see are below.
A: Comparison of molecular weights of co-administered drugs in the study and only doing additional validation on those with the same molecular weight
B: Performing selectivity testing in the presence of each co-administered drug (or set of co-administered drugs) - blank only
C: Performing selectivity testing in the presence of each co-administered drug (or set of co-administered drugs) - blank and LLOQ QC
D: Performing complete selectivity as well as stability assessments in the presence of co-administered drugs
E: Something else - please share
Thanks!
Jennifer
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Jennifer Vance Ph.D.
Dir. of Bioanalytical and Biomarker Development
Recursion Pharmaceuticals
Greenwood IN
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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