Evidence map›Paper›PMID 41369158›Full record

ArticleBioanalysis2025

Method development and validation for simultaneous analysis of four bile acids as CYP3A drug-drug interaction biomarkers.

Zhiyin Xun, Lin Zhang, Ryan McGee, Bob Stratford, Phillip Wang, David Rodrigues

Abstract readValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Bioanalysis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

6 authors.

Zhiyin XunDrug Metabolism and Non-Clinical Pharmacokinetics, Incyte Research Institute, Wilmington, DE, USA.ORCID 0000-0002-9793-4429
Lin ZhangDrug Metabolism and Non-Clinical Pharmacokinetics, Incyte Research Institute, Wilmington, DE, USA.
Ryan McGeeDrug Metabolism and Non-Clinical Pharmacokinetics, Incyte Research Institute, Wilmington, DE, USA.ORCID 0009-0003-7902-0134
Bob StratfordDrug Metabolism and Non-Clinical Pharmacokinetics, Incyte Research Institute, Wilmington, DE, USA.ORCID 0000-0002-9735-0220
Phillip WangDrug Metabolism and Non-Clinical Pharmacokinetics, Incyte Research Institute, Wilmington, DE, USA.ORCID 0009-0007-0400-514X
David RodriguesDrug Metabolism and Non-Clinical Pharmacokinetics, Incyte Research Institute, Wilmington, DE, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo develop and validate a robust LC - MS/MS method for the simultaneous quantification of endogenous deoxycholic acid (DCA), 1β-hydroxydeoxycholic acid (1β-OH-DCA), 1β-hydroxydeoxycholic acid glycine conjugate (1β-OH-G-DCA), and 1β-hydroxydeoxycholic acid taurine conjugate (1β-OH-T-DCA) in human plasma as biomarkers for the assessment of CYP3A-mediated drug-drug interactions (DDI). MATERIALS AND

methodsA surrogate matrix was employed for the preparation of calibration standards and quality control samples. Analytical quantification was achieved using protein precipitation extraction coupled with UHPLC - MS/MS analysis.

resultsA multiplex LC - MS/MS assay was successfully developed and validated for the simultaneous quantification of DCA (4-2000 ng/mL), 1β-OH-DCA (0.05-100 ng/mL), 1β-OH-G-DCA (0.05-100 ng/mL), and 1β-OH-T-DCA (0.05-100 ng/mL) in human plasma. The method effectively addressed the analytical challenges associated with developing an integrated assay for endogenous analytes spanning markedly different concentration ranges and was compliant with the ICH M10 bioanalytical method validation guidance.

conclusionThis is the first report describing the development and validation of a 4-in-1 LC - MS/MS method for the simultaneous quantification of DCA, 1β-OH-DCA, 1β-OH-G-DCA, and 1β-OH-T-DCA in human plasma. The assay provides a robust bioanalytical platform for evaluating CYP3A-mediated DDIs and offers a methodological framework applicable to other multiplexed methods for endogenous biomarkers.

Indexed as

Bile Acids and SaltsCytochrome P-450 CYP3ABiomarkersChromatography, High Pressure LiquidChromatography, LiquidDrug InteractionsHumansTandem Mass SpectrometryBile Acids and SaltsBiomarkersCytochrome P-450 CYP3A1β-hydroxydeoxycholic acidBile acidbioanalysisbiomarkerCYP3Adeoxycholic aciddrug–drug interactionsLC–MS/MS

Identifiers

PMID41369158
PMCPMC12867391

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.