The 2018 FDA Guidance for the Validation of Bioanalytical Methods requires an assessment of the impact of the presence of co-administered drugs on the analytical measurement and stability of novel drug candidates. GLP-compliant methods were developed and validated in support of a clinical study that featured co-administration of itraconazole, paroxetine, cimetidine, moxifloxacin and valproic acid with a proprietary drug candidate. Various methods involving protein-precipitation and liquid–liquid extraction were employed utilizing direct-analysis or dilution of supernatant as well as evaporation with nitrogen followed by reconstitution of analyte in organic solvent.
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