Ivosidenib is a potent and selective small molecule inhibitor of mutant isocitrate dehydrogenase 1. Accurate measurement of ivosidenib is the key to ivosidenib pharmacokinetics in clinical trials. Quantitation of ivosidenib was conducted by using a stable isotope labeled compound (ivosidenib-d) as the internal standard. This assay was validated and successfully applied to support multiple clinical trials. Selected clinical samples were also tested by a chiral LC-MS/MS method against four ivosidenib isomer standards to exclude the possibility of racemization of ivosidenib. A robust LC-MS/MS method was validated for ivosidenib in human plasma. This is the first time for ivosidenib bioanalytical method in any human matrix to be reported.
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| http://dx.doi.org/10.4155/bio-2021-0034 | DOI Listing |
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