volumes

Volume 5 - 2025

Original Research

Published on 13 Mar 2025

Developing decision support algorithm for hypertension medications for use in a digital therapeutic system

Jeannie K. Lee
J. Skye Nicholas
Amani Albadawi
Kathleen C. Insel

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1476998

2,465 views

Editorial

Published on 11 Mar 2025

Editorial: External control arms for single-arm studies: methodological considerations and applications

Deborah Layton
Laura Hester
Asieh Golozar

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1579171

2,573 views

Perspective

Published on 13 Feb 2025

Implementing tokenization in clinical research to expand real-world insights

Chelsea Walters
Crystal S. Langlais
Eva E. Oakkar
Wilhelmina E. Hoogendoorn
James B. Coutcher
Mui Van Zandt

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1519307

4,535 views
1 citation

Volume 4 - 2024

Review

Published on 17 Jan 2025

Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare

Emiliano Giovagnoni
Luisa Mattoli
Andrea Cossu
Vitalia Murgia

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1519142

3,618 views
1 citation

Original Research

Published on 16 Jan 2025

The safety and efficacy of neutral electrolyzed water solution for wound irrigation: post-market clinical follow-up study

Veronika Valdová
Vladimíra Štěpánová
Lenka Lapčíková

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1402684

3,860 views
3 citations

Original Research

Published on 06 Jan 2025

Detection of nontoxic BoNT/A levels in post-facial Botox injection breastmilk

Helene Gu
Zhenyu Xu
Renata Koviazina
Pengcheng Tan
Changcheng Zheng
Ferdinand Kappes
Domna G. Kotsifaki
Fangrong Shen
Anastasia Tsigkou

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1480515

9,053 views
1 citation

Review

Published on 18 Dec 2024

Important tool in our rare disease toolbox: hybrid retrospective-prospective natural history studies serve well as external comparators for rare disease studies

Chinenye Ugoji
Julien Heidt
Joan Largent
Emily Bratton
Laura Hester
Sareh Keshavarzi
Stuart Turner
Christina Mack

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1418050

3,457 views
2 citations

Original Research

Published on 06 Dec 2024

Influence of differential source patterns in the detection of signals of disproportionate reporting for PARP inhibitors

Jordi Mestres

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1497116

2,291 views
1 citation

Mini Review

Published on 13 Nov 2024

Integrating electronic health records with other data sources for postmarket drug safety signal identification: a review

Julie V. Kim
Sharon E. Davis
Michael E. Matheny
Joshua C. Smith

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1428831

3,210 views
3 citations

Editorial

Published on 13 Nov 2024

Editorial: AI/ML in pharmacovigilance and pharmacoepidemiology

Wen Zou
Pantelis Natsiavas
Assaf Gottlieb

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1517365

3,217 views
2 citations

Perspective

Published on 30 Oct 2024

External comparator studies and the joint application of the estimand and target trial emulation frameworks

Gerd Rippin
Héctor Sanz

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1409102

2,710 views
2 citations

Opinion

Published on 18 Sep 2024

Achieving synchrony: bridging the gap between pharmaceutical companies and regulators on safety labeling updates

Tarek A. Hammad
Sasan Sabrdaran
Jean-Marie Heim

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1477516

2,967 views
2 citations

Original Research

Published on 17 Sep 2024

Demonstrating the principal mechanism of action of medical devices intended for vaginal use on reconstructed human vaginal epithelium: the case of two hyaluronic acid-containing devices

Marisa Meloni
Barbara De Servi
Francesco Carriero
Emmanuelle Simon O’Brien
Dounia Houamel
Philippe Deruelle
Vincent Castagné

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1445519

3,549 views
2 citations

Original Research

Published on 16 Aug 2024

Exploring the scientific underpinnings of investigating safety signals: analytical insights in deciphering drug safety evidence

Tarek A. Hammad
Simon Davis
Salman Afsar

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1445998

3,131 views
3 citations

Original Research

Published on 12 Aug 2024

Cohort event monitoring of safety of COVID-19 vaccines: the Italian experience of the “ilmiovaccinoCOVID19 collaborating group”

Nicoletta Luxi
Chiara Bellitto
Francesco Ciccimarra
Emiliano Cappello
Luca L’Abbate
Marco Bonaso
Chiara Ajolfi
Paolo Baldo
Roberto Bonaiuti
Claudio Costantino

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1363086

3,341 views

Original Research

Published on 19 Jul 2024

Measurement error and bias in real-world oncology endpoints when constructing external control arms

Benjamin Ackerman
Ryan W. Gan
Craig S. Meyer
Jocelyn R. Wang
Youyi Zhang
Jennifer Hayden
Grace Mahoney
Jennifer L. Lund
Janick Weberpals
Sebastian Schneeweiss

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1423493

5,611 views
3 citations

Original Research

Published on 27 Jun 2024

Assessing the performance of large language models in literature screening for pharmacovigilance: a comparative study

Dan Li
Leihong Wu
Mingfeng Zhang
Svitlana Shpyleva
Ying-Chi Lin
Ho-Yin Huang
Ting Li
Joshua Xu

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1379260

5,274 views
7 citations

Original Research

Published on 13 May 2024

Progressive multifocal leukoencephalopathy reports in rheumatoid arthritis concerning different treatment patterns-an exploratory assessment using the food and drug administration adverse event reporting system

Takeshi Honma
Kenji Onda
Koichi Masuyama

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1334468

2,674 views
1 citation

Methods

Published on 11 Apr 2024

Application of the target trial emulation framework to external comparator studies

Kellyn Arnold
Luis Antunes
Briana Coles
Hopin Lee

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1380568

5,938 views
4 citations

Opinion

Published on 03 Apr 2024

Regulation 2017/745 on medical devices, two major innovations: 1) the physiological action of devices consisting of natural materials such as vegetal matrices; 2) the chemical-physical-mechanical action of devices made of “substances”, which as such are artificial derivatives

Marcella Marletta

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1389406

2,772 views
1 citation

Original Research

Published on 20 Mar 2024

Machine learning analysis of patients’ perceptions towards generic medication in Greece: a survey-based study

Konstantinos Kassandros
Evridiki Saranti
Evropi Misailidou
Theodora-Aiketerini Tsiggou
Eleftheria Sissiou
George Kolios
Theodoros Constantinides
Christos Kontogiorgis

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1363794

3,240 views
1 citation

Review

Published on 18 Mar 2024

Artificial intelligence for optimizing benefits and minimizing risks of pharmacological therapies: challenges and opportunities

Salvatore Crisafulli
Francesco Ciccimarra
Chiara Bellitto
Massimo Carollo
Elena Carrara
Lisa Stagi
Roberto Triola
Annalisa Capuano
Cristiano Chiamulera
Ugo Moretti

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1356405

6,982 views
10 citations

Editorial

Published on 06 Feb 2024

Editorial: Traditional and innovative approaches for signal detection

Marco Tuccori
Andrew Bate
Ugo Moretti
Gianluca Trifirò

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1373689

2,091 views

Editorial

Published on 05 Feb 2024

Editorial: Treatment of comorbidities of asthma and its safety

Serghei Covantsev
Alexandru Corlateanu

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1366847

1,453 views