Bioanalysis Zone

A multiplex HRMS assay for quantifying selected human plasma bile acids as candidate OATP biomarkers

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Aim: Selected bile acids (BAs) in plasma have been proposed as endogenous probes for assessing drug–drug interactions involving hepatic drug transporters such as the organic anion-transporting polypeptides (OATP1B1 and OATP1B3).

The cost and time required to advance a new chemical entity (NCE) to market is well documented, which encompasses clinical studies aimed at providing absorption, distribution, metabolism and excretion information to support registration [1–4]. In particular, NCEs are studied as drug–drug interaction (DDI) victims and perpetrators, especially when a specific NCE–drug combination impacts efficacy and patient safety in a clinically meaningful manner [1]. Therefore, the industry has relied increasingly on in vitro data and the screening of NCEs as inhibitors and substrates of various drug-metabolizing enzymes and transporters has become widespread [2–4]. However, even with such well-defined methods, the US FDA recently reported

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