Therapeutic Drug Monitoring: Techniques and Applications in Pharmaceutical Analysis

A special issue of Pharmaceuticals (ISSN 1424-8247).

Deadline for manuscript submissions: 25 January 2026 | Viewed by 622

Special Issue Editors


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Guest Editor
1. Department of Pharmaceutical Analysis and Nuclear Pharmacy, Faculty of Pharmacy, Comenius University Bratislava, Odbojarov 10, 832 32 Bratislava, Slovakia
2. Toxicological and Antidoping Center, Faculty of Pharmacy, Comenius University Bratislava, Odbojarov 10, 832 32 Bratislava, Slovakia
Interests: CE-MS/MS; LC-MS/MS; green analytical methods; method development; therapeutic drug monitoring; bioanalytical method validation; antibiotics; Janus kinase inhibitors; pharmacokinetics

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Guest Editor
1. Institute of Neuroimmunology, Slovak Academy of Sciences, Bratislava, Slovak Republic
2. Department of Galenic Pharmacy, Faculty of Pharmacy, Comenius University in Bratislava, Bratislava, Slovak Republic
3. Toxicological and Antidoping Center, Faculty of Pharmacy, Comenius University in Bratislava, Bratislava, Slovak Republic
Interests: capillary electrophoresis; liquid chromatography; mass spectrometry; biologics; therapeutic drug monitoring; bioanalysis; quality control; therapeutic peptides
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Special Issue Information

Dear Colleagues,

Therapeutic Drug Monitoring (TDM) is an essential part of modern pharmacotherapy, allowing for the individualization of drug dosing through the measurement of drug concentrations in biological matrices such as blood, plasma, or saliva. It is particularly important for medications with a narrow therapeutic window, high interindividual variability, or a risk of significant toxicity. In recent years, advances in analytical technologies have greatly enhanced the precision, sensitivity, and speed of TDM workflows.

This Special Issue welcomes a wide range of contributions that reflect the interdisciplinary nature of TDM. We are especially interested in studies focused on the development and validation of analytical methods, innovative sample preparation strategies, and bioanalytical challenges. Equally, we invite submissions addressing pharmacokinetic and pharmacodynamic modeling, individualized dosing strategies, and the application of TDM in special patient populations. Research exploring how TDM supports personalized and precision medicine is particularly encouraged.

By bringing together pharmaceutical scientists, clinicians, and analytical chemists, this Special Issue aims to provide a comprehensive overview of current trends and innovations in TDM, and to showcase its impact on safer and more effective drug therapy.

Dr. Ivana Cizmarova
Dr. Juraj Piestansky
Guest Editors

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Keywords

  • Therapeutic Drug Monitoring (TDM)
  • bioanalytical method development
  • LC-MS/MS
  • sample preparation
  • method validation
  • pharmacokinetics
  • pharmacodynamics
  • individualized dosing
  • precision medicine
  • clinical applications

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Published Papers (1 paper)

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Research

21 pages, 1797 KB  
Article
Volumetric Absorptive Microsampling of Saliva for Pharmacokinetic Evaluation of Mycophenolic Acid and Its Glucuronide Metabolite in Pediatric Renal Transplant Recipients: Bioanalytical Method Validation and Clinical Feasibility Evaluation
by Arkadiusz Kocur, Joanna Sobiak, Agnieszka Czajkowska, Jacek Rubik and Tomasz Pawiński
Pharmaceuticals 2025, 18(11), 1744; https://doi.org/10.3390/ph18111744 - 17 Nov 2025
Viewed by 254
Abstract
Background: Mycophenolic acid (MPA) is frequently used in pediatric renal transplantation as part of immunosuppressive therapy, yet therapeutic drug monitoring (TDM) remains challenging. Accurate monitoring is essential due to MPA’s narrow therapeutic window, variable pharmacokinetics, and high protein binding. This study examined whether [...] Read more.
Background: Mycophenolic acid (MPA) is frequently used in pediatric renal transplantation as part of immunosuppressive therapy, yet therapeutic drug monitoring (TDM) remains challenging. Accurate monitoring is essential due to MPA’s narrow therapeutic window, variable pharmacokinetics, and high protein binding. This study examined whether saliva could serve as a non-invasive alternative to plasma for measuring MPA exposure. Methods and Results: Concentrations of MPA and its primary glucuronide metabolite (MPAG) were determined in plasma, capillary blood, plasma ultrafiltrate, wet saliva, and dried saliva collected using volumetric absorptive microsampling (VAMS). A novel LC–MS/MS method for quantifying MPA and MPAG in dried saliva collected with the Mitra™ device was developed and validated within a 1–700 μg/L calibration range, demonstrating robust analytical performance. Dried and wet saliva showed high correlation (r = 0.99 and 0.98 for MPA and MPAG, respectively). However, both salivary matrices—dried saliva collected with Mitra™ (vsMPA, vsMPAG) and wet saliva (sMPA, sMPAG)—exhibited poor correlation with unbound (fMPA, fMPAG) and total plasma concentrations (tMPA, tMPAG). A modest, yet positive, correlation was observed between the measured concentrations for the following pairs: sMPA versus fMPA (r = 0.376, p = 0.1036), sMPA versus tMPA (r = 0.305, p = 0.1904), sMPAG versus fMPAG (r = 0.205, p = 0.3851), and sMPAG versus tMPAG (r = 0.472, p = 0.0012). Pharmacokinetic parameters supported these findings, highlighting discrepancies between saliva and plasma. Conclusions: From a clinical perspective, saliva sampling—although minimally invasive and patient-friendly—does not offer a reliable substitute for plasma in routine TDM of MPA and MPAG. Capillary blood collected through VAMS remains a promising alternative for long-term monitoring of pediatric patients; however, several considerations still need to be addressed. Full article
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