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Pharmaceutics
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Therapeutic Drug Monitoring as a Useful Tool in Therapy Improvement,...
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Therapeutic Drug Monitoring as a Useful Tool in Therapy Improvement, 3rd Edition

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Clinical Pharmaceutics".

Deadline for manuscript submissions: 30 June 2026 | Viewed by 3035

Special Issue Editors

Dr. Andrzej Czyrski

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Guest Editor
Department of Physical Pharmacy and Pharmacokinetics, Poznań University of Medical Sciences, 60-781 Poznan, Poland
Interests: drug analysis; pharmacokinetics; aritficial neural networks; data mining; drug–drug interactions
Special Issues, Collections and Topics in MDPI journals
Dr. Matylda Resztak

E-Mail Website
Guest Editor
Department of Physical Pharmacy and Pharmacokinetics, Poznań University of Medical Sciences, Poznan, Poland
Interests: therapeutic drug monitoring; HPLC; method validation; polymorphism; pharmacokinetics
Special Issues, Collections and Topics in MDPI journals
Dr. Joanna Sobiak

E-Mail Website
Guest Editor
Department of Physical Pharmacy and Pharmacokinetics, Poznań University of Medical Sciences, Poznan, Poland
Interests: therapeutic drug monitoring; pediatrics; analytical methods; population pharmacokinetics; drug–drug interactions
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Responses to therapy may vary between patients. Therapeutic drug monitoring is helpful for addressing this phenomenon. This Special Issue is targeted towards authors whose work focuses on therapeutic drug monitoring. We invite submissions concerning observed drug–drug interactions based on the effects of drug concentrations on biological matrices, as well as their pharmacokinetic impacts. Original papers concerning new drugs for which therapeutic drug monitoring may be beneficial are also welcome, as are those focused on new approaches for therapeutic drug monitoring. Interactions in the pharmacokinetic phase may also be observed in animal models; however, they must be relevant to the human body. In this context, papers concerning pharmacokinetic interactions in both human and animal models are welcome. We also encourage manuscripts in which machine learning techniques are applied in TDM or in the evaluation of side effects of pharmacotherapy. This Special Issue will include original and review articles.

Dr. Andrzej Czyrski
Dr. Matylda Resztak
Dr. Joanna Sobiak
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 250 words) can be sent to the Editorial Office for assessment.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • drug–drug interactions
  • pharmacokinetics
  • therapeutic drug monitoring
  • machine learning

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Published Papers (3 papers)

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Research

17 pages, 1539 KB  
Article
Development and Validation of LC-MS/MS Method for Nintedanib and BIBF 1202 Monitoring in Plasma of Patients with Progressive Pulmonary Fibrosis Associated with Systemic Sclerosis
by Anna Kiełczyńska, Edyta Gilant, Tomasz Pawiński, Iwona Szlaska, Katarzyna Buś-Kwaśnik, Edyta Pesta, Daria Kuc and Brygida Kwiatkowska
Pharmaceutics 2025, 17(12), 1553; https://doi.org/10.3390/pharmaceutics17121553 - 2 Dec 2025
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Abstract
Background: Nintedanib (NIN), an intracellular inhibitor of tyrosine kinases that inhibits processes fundamental to the progression of pulmonary fibrosis (PPF), is used in the treatment of patients with PPF associated with systemic sclerosis. During NIN therapy, adverse events lead to a permanent [...] Read more.
Background: Nintedanib (NIN), an intracellular inhibitor of tyrosine kinases that inhibits processes fundamental to the progression of pulmonary fibrosis (PPF), is used in the treatment of patients with PPF associated with systemic sclerosis. During NIN therapy, adverse events lead to a permanent dose reduction and treatment discontinuation. Therapeutic drug monitoring (TDM) can be used to manage and optimize drug administration based on the measurement of drug concentrations. Therefore, TDM can be helpful in minimizing the impact of adverse events and help patients remain in therapy. The aim of this study was to develop and validate a new bioanalytical UPLC-MS/MS method enabling the determination of NIN and its active metabolite in the plasma of patients with PPF associated with systemic sclerosis. Methods: Sample preparation was carried out using protein precipitation with an extraction mixture: acetonitrile neutralized with 2 M sodium carbonate. Analytes and the internal standard (intedanib-d3) were monitored using mass spectrometry (MS) and positive-ion-mode electrospray ionization by MRM. Chromatographic analysis was performed on a Zorbax SB-C18 column kept at 40 °C using isocratic elution. The mobile phase contained 0.1% formic acid in water; acetonitrile (35:65 v/v) was pumped at a flow rate of 0.3 mL/min. The analysis time was 5 min. Results: The method was verified according to the EMA guidelines over a concentration range of 2.00–200.00 ng/mL. The correlation coefficients for the calibration curves were found to be 0.9991 and 0.9957 for NIN and its metabolite BIBF 1202, respectively. The within- and between-run precision and accuracy of LLOQ were evaluated for NIN and BIBF 1202 to be within RSD 2.96%, 4.53%, 5.51%, and 6.72% and in the ranges of 102.2–107.3%, 98.0–101.8%, 104.3–114.2%, and 99.1–104.9, respectively. The stability of the analytes in plasma after 4 h at 30 °C was found to be satisfactory, meeting the assumed bias criteria below 15%. Conclusions: The proposed method was successfully applied to analyze two active compounds—NIN and BIBF 1202—in plasma samples at two time points: trough (pre-dose concentration) and 2–3 h (maximum concentration) after the administration of NIN. Full article
(This article belongs to the Special Issue Therapeutic Drug Monitoring as a Useful Tool in Therapy Improvement, 3rd Edition)
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15 pages, 4863 KB  
Article
Estimated Glomerular Filtration Rate Variability in Patients with Diabetes Receiving SGLT2 Inhibitors Versus DPP4 Inhibitors
by Yi-Wei Kao, Tze-Fan Chao, Yu-Wen Cheng, Shao-Wei Chen and Yi-Hsin Chan
Pharmaceutics 2025, 17(11), 1370; https://doi.org/10.3390/pharmaceutics17111370 - 23 Oct 2025
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Abstract
Background: Major clinical trials regarding sodium–glucose cotransporter 2 inhibitors (SGLT2is) have focused on estimated glomerular filtration rate (eGFR) slope and composite kidney outcomes, with limited evaluation of eGFR variability as a kidney outcome or its long-term implications in patients receiving SGLT2i versus placebo. [...] Read more.
Background: Major clinical trials regarding sodium–glucose cotransporter 2 inhibitors (SGLT2is) have focused on estimated glomerular filtration rate (eGFR) slope and composite kidney outcomes, with limited evaluation of eGFR variability as a kidney outcome or its long-term implications in patients receiving SGLT2i versus placebo. Methods: This retrospective study analyzed 3777 propensity score-matched patients with type 2 diabetes receiving either SGLT2i or dipeptidyl peptidase-4 inhibitor (DPP4i) between June 2016 and December 2021. Each patient had eGFR data at three time points before (−15, −9, and −3 months) and after (3, 9, and 15 months) the drug-index date. eGFR variability was assessed using the coefficient of variation (COV) and standard deviation (SD) of eGFR values. Results: SGLT2i therapy was associated with a significant reduction in eGFR variability by both COV (from 0.072 (0.001) to 0.069 (0.001); p = 0.014) and SD (mL/min/1.73 m2) (from 5.34 (0.07) to 4.82 (0.07); p < 0.001). In contrast, DPP4i therapy resulted in increased COV (from 0.072 (0.001) to 0.080 (0.001); p < 0.001) and no significant improvement in SD (from 5.06 (0.07) to 5.22 (0.07); p = 0.082). Greater reduction in eGFR variability was observed in SGLT2i relative to DPP4i with high pre-treatment eGFR variability, pre-existing chronic kidney disease, or rapid pre-treatment eGFR decline. Greater pre-treatment eGFR variability predicted risk of major adverse kidney events (MAKEs) and abrupt kidney decline in DPP4i-treated patients, but not in those on SGLT2is. SGLT2i consistently reduced the risk of MAKE and abrupt kidney decline across the spectrum of pre-treatment eGFR variability, with a greater risk reduction on the MAKE for SGLT2i versus DPP4i therapy with a higher pre-treatment eGFR variability estimated by SD (p interaction = 0.014). Conclusions: SGLT2i therapy improved eGFR variability and reduced the risk of adverse kidney outcomes compared to DPP4i, particularly in patients with higher pre-treatment eGFR variability. Full article
(This article belongs to the Special Issue Therapeutic Drug Monitoring as a Useful Tool in Therapy Improvement, 3rd Edition)
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16 pages, 365 KB  
Article
Sex-Specific Differences in Antidepressant and Antipsychotic Treatment Outcomes and Serum Levels in Children and Adolescents
by Maike Scherf-Clavel, Stefanie Fekete, Manfred Gerlach, Christoph U. Correll, Paul Plener, Jörg M. Fegert, Andreas Karwautz, Peter Heuschmann, Tobias Banaschewski, Wolfgang Briegel, Christian Fleischhaker, Tobias Hellenschmidt, Hartmut Imgart, Michael Kaess, Michael Kölch, Karl Reitzle, Tobias J. Renner, Christian Rexroth, Gerd Schulte-Körne, Frank Theisen, Susanne Walitza, Christoph Wewetzer, Franca Keicher, Stefan Unterecker, Sebastian Walther, Marcel Romanos, Karin M. Egberts, Timo Vloet and Regina Taurinesadd Show full author list remove Hide full author list
Pharmaceutics 2025, 17(8), 983; https://doi.org/10.3390/pharmaceutics17080983 - 30 Jul 2025
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Abstract
Introduction: Sex-specific differences in psychopharmacological treatment have gained increasing attention in adults, with studies showing that women often have higher serum concentrations of psychotropic drugs due to biological differences. However, despite recognition of these differences in adults, reference ranges for therapeutic drug monitoring [...] Read more.
Introduction: Sex-specific differences in psychopharmacological treatment have gained increasing attention in adults, with studies showing that women often have higher serum concentrations of psychotropic drugs due to biological differences. However, despite recognition of these differences in adults, reference ranges for therapeutic drug monitoring (TDM) in general, but even more sex-specific therapeutic windows for psychotropic drugs, are lacking in children and adolescents, who may metabolize and respond to medications differently. Aim: The study aimed to investigate sex-specific differences in antidepressant (AD) and antipsychotic (AP) -treatment outcomes, and pharmacokinetics in childhood/adolescence. In particular, we examined differences in AD and AP serum levels and clinical effects, including adverse drug effects (ADEs) and therapeutic effectiveness. Methods: This study is part of the multicenter “TDM-VIGIL” pharmacovigilance project, which prospectively followed patients aged 6–18 years treated with AD and AP across 18 child psychiatric centers in German-speaking countries from 2014 to 2018. Clinical data, including drug concentrations (AD: fluoxetine, mirtazapine, (es)citalopram, sertraline; AP: aripiprazole, quetiapine, olanzapine, risperidone), were collected using an internet-based registry, and treatment outcomes and ADEs were assessed during routine visits. Statistical analyses were performed to examine sex differences in pharmacokinetics and clinical responses, adjusting for age, weight, and other confounders. Results: A total of 705 patients (66.5% girls, 24.7% <14 years, mean age of 14.6 years) were included. Female patients were slightly older, had lower body weight, and were more often diagnosed with depression and anorexia nervosa, while boys were more frequently diagnosed with hyperkinetic disorders and atypical autism. We found no sex differences in the serum concentrations of investigated drugs when adjusted for age and weight. In fluoxetine treatment in patients diagnosed with mood (affective) disorders, female sex was associated with the probability for very good therapy response (p = 0.04), as well as with moderate treatment response (p = 0.02) compared to no treatment response. Discussion: Our findings suggest that sex may not affect serum levels of investigated AD and AP in children/adolescents. However, treatment outcome of fluoxetine was associated with sex, with higher probability for a better outcome in female patients diagnosed with mood (affective) disorders. Full article
(This article belongs to the Special Issue Therapeutic Drug Monitoring as a Useful Tool in Therapy Improvement, 3rd Edition)
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