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Application of Mass Spectrometry and Chromatography in Drug Monitoring

A special issue of International Journal of Molecular Sciences (ISSN 1422-0067). This special issue belongs to the section "Biochemistry".

Deadline for manuscript submissions: 20 September 2025 | Viewed by 685

Special Issue Editor


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Guest Editor
Therapeutic Drug Monitoring Laboratory, Pharmacology at the Laboratory Diagnostic Centre, University Hospital of Cologne, Cologne, Germany
Interests: therapeutic drug monitoring; LC-MS method development; method validation; pharmacometrics; pediatric clinical pharmacology; HR-MS; laboratory developed tests; clinical mass spectrometry

Special Issue Information

Dear Colleagues,

Mass spectrometry (MS) in terms of clinical mass spectrometry arises great opportunities in clinical basic science and healthcare services. As the gold standard in pharmaceutical and clinical instrumental analytics, it serves as a powerful “tool” to encourage pharmacokinetic analysis of clinical studies/data and measurements for the individualization of pharmacotherapy of new drugs and metabolites in particular. Therefore, the scientists and staff members have to be familiar with regulatory affairs and use of fully validated in-house tests/laboratory-developed tests (LDTs) according to international valid regulations. Moreover, high-resolution mass spectrometry is the most promising technology for the detection and determination of the monoclonal antibody (mAb) structure, although the quantification of native proteins remains a challenge. The implementation of MS into a drug monitoring laboratory setting has the greatest potential to optimize actual immunotherapies with mAbs by far. Nevertheless, drug monitoring is not required for every drug. Measurement of drug levels is recommended based on national and international guidance documents. A drug monitoring service should be carried out in compliance with the indications and the need in the context of pharmacotherapy.

Prof. Dr. Carsten Müller
Guest Editor

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Keywords

  • therapeutic drug monitoring
  • method validation
  • pharmacometrics
  • pediatric clinical pharmacology
  • laboratory developed tests
  • clinical mass spectrometry
  • functional tests
  • isobars
  • triple quad mass spectrometry
  • HR-MS
  • biomarker
  • drugs of abuse
  • therapeutic drugs
  • metabolites

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Published Papers (1 paper)

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Research

16 pages, 3373 KiB  
Article
Automated Workflow for High-Throughput LC–MS/MS Therapeutic Monitoring of Cannabidiol and 7-Hydroxy-cannabidiol in Patients with Epilepsy
by Michela Palmisani, Francesca Dattrino, Paola Rota, Federica Tacchella, Guido Fedele, Ludovica Pasca, Carlo Alberto Quaranta, Valentina De Giorgis, Thomas Matulli Cavedagna, Chiara Cancellerini, Anna Butti, Gloria Castellazzi, Emilio Russo, Cristina Tassorelli, Pierluigi Nicotera and Valentina Franco
Int. J. Mol. Sci. 2025, 26(14), 6999; https://doi.org/10.3390/ijms26146999 - 21 Jul 2025
Viewed by 301
Abstract
This study describes the development and validation of a fully automated workflow for serum sample preparation, enabling the quantitative determination of cannabidiol (CBD) and its active metabolite, 7-hydroxy-CBD, via liquid chromatography coupled with tandem mass spectrometry (LC–MS/MS) analysis. Implemented on an automated platform, [...] Read more.
This study describes the development and validation of a fully automated workflow for serum sample preparation, enabling the quantitative determination of cannabidiol (CBD) and its active metabolite, 7-hydroxy-CBD, via liquid chromatography coupled with tandem mass spectrometry (LC–MS/MS) analysis. Implemented on an automated platform, the workflow performs key steps such as solvent dispensing, mixing, centrifugation, filtration, and supernatant transfer, producing 96-well plates ready for analysis. Human serum samples were obtained from patients with epilepsy treated with CBD. All samples were processed using both manual and automated methods to evaluate method agreement. Quantification was performed by LC–MS/MS with CBD-d3 as the internal standard (IS). Method validation was conducted in accordance with European Medicine Agency (EMA) guidelines, confirming that the automated protocol meets the recommended acceptance criteria for both intraday and interday precision and accuracy. Calibration curves demonstrated excellent linearity across the concentration ranges. Comparative analysis using Passing–Bablok regression and Bland–Altman plots demonstrated strong agreement between the methods. These findings support the clinical applicability of the automated method for the therapeutic drug monitoring (TDM) of CBD and 7-hydroxy-CBD, and its robust performance and scalability provide a solid foundation for the development of an expanded analytical panel covering a broader range of antiseizure medications (ASMs), enabling more standardized TDM protocols in clinical practice. Full article
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