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Pharmaceuticals
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Therapeutic Drug Monitoring and Adverse Drug Reactions: 2nd Edition
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Therapeutic Drug Monitoring and Adverse Drug Reactions: 2nd Edition

A special issue of Pharmaceuticals (ISSN 1424-8247). This special issue belongs to the section "Pharmacology".

Deadline for manuscript submissions: 25 April 2025 | Viewed by 814

Special Issue Editors

Dr. Engi Abd El Hady Algharably

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Guest Editor
Charité–Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Clinical Pharmacology and Toxicology, Charitéplatz 1, 10117 Berlin, Germany
Interests: clinical pharmacokinetics; pharmacogenetics; risk assessment; pbpk modeling; hypertension
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Ursula Gundert-Remy

E-Mail Website
Guest Editor
Charité–Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Clinical Pharmacology and Toxicology, Charitéplatz 1, 10117 Berlin, Germany
Interests: toxicokinetics; toxicity; pharmacokinetics; bioavailability; clinical pharmacokinetics pharmacokinetic modeling; pkpd modeling; pharmacovigilance; risk assessment; toxicology
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Therapeutic drug monitoring (TDM) and the prevention of adverse drug reactions (ADRs) are of utmost importance in optimizing patient care and medication safety. To explore the latest advancements and insights in this field, Pharmaceuticals is pleased to continue the journey with the second volume of the Special Issue “. In this Special Issue, we aim to provide a platform for researchers, clinicians, and pharmacologists to present their original research, reviews, and case studies related to TDM and ADRs which have translational impact on drug users.

The Special Issue seeks contributions covering various topics related to medication safety in the context of TDM methodologies or studies focusing on the subtopic of ADRs. Relevant research work focusing on novel methodologies for TDM, individualized dosing strategies, biomarkers for predicting drug response and ADRs, strategies for minimizing ADRs and enhancing medication safety, pharmacokinetic modeling, as well as pharmacogenomics.

By exploring these themes, this Special Issue aims to enhance our understanding of drug efficacy, toxicity, and personalized treatment strategies. It seeks to highlight the importance of TDM and its implementation in clinical practice in order to minimize ADRs and improve patient outcomes using all available research disciplines. We welcome and encourage researchers and clinicians to submit their high-quality manuscripts to contribute to the advancements in therapeutic drug monitoring and adverse drug reactions.

Dr. Engi Abd El Hady Algharably
Prof. Dr. Ursula Gundert-Remy
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 100 words) can be sent to the Editorial Office for announcement on this website.

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. Pharmaceuticals 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

  • therapeutic drug monitoring
  • adverse drug reactions
  • pharmacokinetics
  • personalized medicine
  • medication safety
  • pharmacogenomics
  • medication review
  • pharmacokinetic modelling

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Published Papers (1 paper)

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Research

16 pages, 1061 KiB  
Article
Post-Marketing Pharmacovigilance of Canakinumab from the FDA Adverse Event Reporting System (FAERS)
by Weidong Zhang, Yunzhou Chen, Zeyu Yao, Mengling Ouyang, Minghui Sun and Shupeng Zou
Pharmaceuticals 2025, 18(1), 114; https://doi.org/10.3390/ph18010114 - 16 Jan 2025
Viewed by 605
Abstract
Background: Canakinumab, a humanized anti-IL-1β monoclonal antibody, is known for its ability to suppress IL-1β-mediated inflammation. However, continuous monitoring of its safety remains essential. Thus, we comprehensively evaluated the safety signals of canakinumab by data mining from FAERS. Methods: We used a disproportionate [...] Read more.
Background: Canakinumab, a humanized anti-IL-1β monoclonal antibody, is known for its ability to suppress IL-1β-mediated inflammation. However, continuous monitoring of its safety remains essential. Thus, we comprehensively evaluated the safety signals of canakinumab by data mining from FAERS. Methods: We used a disproportionate analysis to quantify canakinumab-related adverse events (AEs) using four algorithms. Clinical prioritization of the detected signals was assessed with a semiquantitative score method. Serious and non-serious outcomes were compared by statistical methods. Additionally, a stratification analysis of serious infections was conducted at the system organ class (SOC) level. Results: A total of 28,496 canakinumab-related AEs were collected, and 71 suspicious signals detected. Among these, 19 preferred terms (PTs) were identified as unexpected signals, including deafness, appendicitis, brain oedema, cushingoid, cellulitis, and papilledema. Of the AEs, 16 were more likely reported as serious outcomes, such as pneumonia, abdominal pain, deafness, and infection. Based on clinical priority score, 44 PTs were classified as weak, 27 as moderate, and none as strong. Furthermore, 30 PTs demonstrated a high level of evidence, primarily derived from FDA prescribing information, randomized controlled trials, and systematic reviews. Stratification analysis of infections and infestations (serious outcomes) revealed a stronger association of severe infections with canakinumab in older or heavier individuals. All positive signals followed an early failure pattern, with the incidence of canakinumab-associated AEs decreasing over time. Conclusions: We found that most of the suspicious signals were associated with infections. More attention should be paid to serious infections, particularly in males, individuals aged ≥60 years, or those weighing >100 kg, who demonstrated the highest risk of serious infections. Full article
(This article belongs to the Special Issue Therapeutic Drug Monitoring and Adverse Drug Reactions: 2nd Edition)
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