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Novel Epidemiological Approaches in Clinical Pharmacology and Toxicology
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Novel Epidemiological Approaches in Clinical Pharmacology and Toxicology

A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Pharmacology".

Deadline for manuscript submissions: closed (20 January 2025) | Viewed by 4026

Special Issue Editors

Dr. Niccolò Lombardi

E-Mail Website
Guest Editor
1. Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, 50141 Florence, Italy
2. Tuscan Regional Centre of Pharmacovigilance, 50122 Florence, Italy
Interests: clinical pharmacology and toxicology; pharmacovigilance and pharmacoepidemiology
Special Issues, Collections and Topics in MDPI journals
Dr. Giada Crescioli

E-Mail Website
Guest Editor
1. Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, 50141 Florence, Italy
2. Tuscan Regional Centre of Pharmacovigilance, 50122 Florence, Italy
Interests: clinical pharmacology and toxicology; pharmacovigilance and pharmacoepidemiology
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Novel epidemiological approaches in clinical pharmacology and toxicology aim to enhance our understanding of how drugs affect populations and individuals. These approaches utilize advanced methodologies, data sources, and analytical techniques to investigate the safety, efficacy, and toxicity of drugs. Some of the emerging trends and approaches in this field are represented by real-world data (RWD) and real-world evidence (RWE), Bayesian methods, network pharmacology, longitudinal data analysis, and machine learning and artificial intelligence (AI).

In recent years, novel epidemiological approaches have had a broad and far-reaching impact on clinical pharmacology, toxicology, epidemiology, and other fields.

We have launched a Special Issue, “Novel Epidemiological Approaches in Clinical Pharmacology and Toxicology”, and we encourage you and your colleagues to submit articles related to clinical pharmacology, toxicology, and epidemiology with a focus on new research methodologies. Original research articles and reviews are welcome.

Dr. Niccolò Lombardi
Dr. Giada Crescioli
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. Journal of Clinical Medicine is an international peer-reviewed open access semimonthly 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 2600 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

  • clinical pharmacology
  • toxicology
  • epidemiology
  • the value of real-world evidence
  • adverse drug reactions
  • drug safety

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Further information on MDPI's Special Issue policies can be found here.

Published Papers (3 papers)

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Research

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27 pages, 1875 KiB  
Article
Comparative Analysis of Neuropsychiatric Adverse Reactions Associated with Remdesivir and Nirmatrelvir/Ritonavir in COVID-19 Treatment: Insights from EudraVigilance Data
by Aliteia-Maria Pacnejer, Mihaela Cristina Negru, Anca Maria Arseniu, Cristina Trandafirescu, Cristian Oancea, Felicia Gabriela Gligor, Claudiu Morgovan, Anca Butuca and Cristina Adriana Dehelean
J. Clin. Med. 2025, 14(6), 1886; https://doi.org/10.3390/jcm14061886 - 11 Mar 2025
Cited by 1 | Viewed by 598
Abstract
Remdesivir (RDV) and nirmatrelvir/ritonavir (NMVr) are among the most widely used antivirals in the treatment of COVID-19, aiming to reduce disease severity and progression. Adverse neuropsychiatric effects, such as anxiety, sleep disturbances, and movement disorders, have emerged as significant concerns associated with these [...] Read more.
Remdesivir (RDV) and nirmatrelvir/ritonavir (NMVr) are among the most widely used antivirals in the treatment of COVID-19, aiming to reduce disease severity and progression. Adverse neuropsychiatric effects, such as anxiety, sleep disturbances, and movement disorders, have emerged as significant concerns associated with these treatments. To better understand the safety profiles of RDV and NMVr, this study performs a pharmacovigilance analysis of individual case safety reports (ICSRs) from the EudraVigilance (EV) database. Objectives: This study evaluates the risk of neuropsychiatric adverse events associated with RDV and NMVr. Comparisons with other antiviral drugs, including darunavir, sofosbuvir, ribavirin, tenofovir, ritonavir, and sotrovimab, are also performed to develop a comprehensive understanding of the safety profiles. Methods: A retrospective analysis of ICSRs submitted to EV until 7 July 2024, with data extraction on 12 July 2024, was conducted. Demographic characteristics (age, sex, geographic region, and reporter type) and case severity were included in the descriptive analysis. Disproportionality analysis using reporting odds ratio (ROR) and 95% confidence intervals (CI) was performed to compare adverse drug reaction (ADRs) frequencies across 27 system organ classes (SOCs), with emphasis on “Nervous system disorders” and “Psychiatric disorders. Results: The total number of ICSRs was significantly higher for NMVr (n = 8078) compared to RDV (n = 3934). Nervous system disorders accounted for 3.07% of the total RDV reports and for 17.31% of NMVr reports, while psychiatric disorders represented 0.92% of the total ADRs reported for RDV (n = 60) and 3.61% for NMVr (n = 672). On the other hand, RDV showed a significantly lower frequency of reporting headache compared to NMVr (ROR: 0.1057; 95% CI: 0.0676–0.1653). Conclusions: NMVr presents a higher risk of neuropsychiatric ADRs than RDV, underscoring the need for enhanced monitoring, particularly in patients with preexisting central nervous system (CNS) conditions. These findings contribute to optimizing antiviral safety and informing clinical decision making. Full article
(This article belongs to the Special Issue Novel Epidemiological Approaches in Clinical Pharmacology and Toxicology)
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13 pages, 1022 KiB  
Article
Two Years of Active Pharmacovigilance Surveillance and Therapeutic Reconciliation in Frail Populations: The MEAP 3.0 Study
by Anna Bombelli, Greta Guarnieri, Niccolò Lombardi, Maria Giuseppa Sullo, Edoardo Spina, Giada Crescioli, Concetta Rafaniello, Giuseppe Cicala, Veronica Marangon, Rachele Folchino, Silvia Vecchio, Giulia Mosini, Sonia Radice, Emilio Clementi and MEAP 3.0 Group
J. Clin. Med. 2023, 12(23), 7447; https://doi.org/10.3390/jcm12237447 - 30 Nov 2023
Viewed by 1447
Abstract
Awareness related to the risk/benefit profile of therapies used in paediatric and elderly patients is limited. We carried out a study, called the MEAP 3.0 study, to collect and analyse evidence of adverse drug reactions (ADRs) and drug–drug interactions (DDIs) that occurred in [...] Read more.
Awareness related to the risk/benefit profile of therapies used in paediatric and elderly patients is limited. We carried out a study, called the MEAP 3.0 study, to collect and analyse evidence of adverse drug reactions (ADRs) and drug–drug interactions (DDIs) that occurred in frail populations under polypharmacy in a real-world setting. Data were retrieved from reports of ADRs and pharmacological counselling from patients treated in hospitals and territorial health services. We collected 2977 ADRs reports and identified ‘anti-infectives for systemic use’ and ‘cardiovascular system’ as the most frequently implicated pharmacological classes in under-18 and over-65 patients, respectively. We detected 2179 DDIs, of which 10.7% were related to at least one ADR: 22 were classified as ‘contraindicated’ (7 in the paediatric group and 15 in the elderly one), and 61 as ‘major’ (6 in the paediatric patients and 55 in the geriatric ones), while 151 DDIs were classified as ‘moderate’ (10 referred to paediatric population, and 109 to elderly patient) and as ‘minor’ (1 in paediatric patients, and 31 in the elderly ones). The MEAP 3.0 project demonstrates that pharmacovigilance surveillance and therapeutic reconciliation are valid strategies to avoid potential DDIs and the occurrence of ADRs, allowing for personalised medicine. Full article
(This article belongs to the Special Issue Novel Epidemiological Approaches in Clinical Pharmacology and Toxicology)
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Review

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13 pages, 1818 KiB  
Review
Ranolazine Unveiled: Rediscovering an Old Solution in a New Light
by Giulia Azzurra De Santis, Tommaso De Ferrari, Francesca Parisi, Marco Franzino, Agustin Ezequiel Molinero, Alessandro Di Carlo, Lorenzo Pistelli, Giampaolo Vetta, Antonio Parlavecchio, Marco Torre, Matteo Parollo, Giacomo Mansi, Pietro Paolo Tamborrino, Antonio Canu, Gino Grifoni, Luca Segreti, Andrea Di Cori, Stefano Marco Viani and Giulio Zucchelli
J. Clin. Med. 2024, 13(17), 4985; https://doi.org/10.3390/jcm13174985 - 23 Aug 2024
Viewed by 1434
Abstract
Ranolazine is an anti-anginal medication that has demonstrated antiarrhythmic properties by inhibiting both late sodium and potassium currents. Studies have shown promising results for ranolazine in treating both atrial fibrillation and ventricular arrhythmias, particularly when used in combination with other medications. This review [...] Read more.
Ranolazine is an anti-anginal medication that has demonstrated antiarrhythmic properties by inhibiting both late sodium and potassium currents. Studies have shown promising results for ranolazine in treating both atrial fibrillation and ventricular arrhythmias, particularly when used in combination with other medications. This review explores ranolazine’s mechanisms of action and its potential role in cardiac arrhythmias treatment in light of previous clinical studies. Full article
(This article belongs to the Special Issue Novel Epidemiological Approaches in Clinical Pharmacology and Toxicology)
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