Frontiers in Drug Safety and Regulation

Original Research

Published on 13 Mar 2025

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

in Clinical Drug Safety

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

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1476998

2,472 views

Editorial

Published on 11 Mar 2025

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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Deborah Layton
Laura Hester
Asieh Golozar

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1579171

2,574 views

Perspective

Published on 13 Feb 2025

Implementing tokenization in clinical research to expand real-world insights

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

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

4,537 views
1 citation

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

in Substance-Based Medical Devices

Emiliano Giovagnoni
Luisa Mattoli
Andrea Cossu
Vitalia Murgia

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1519142

3,628 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

in Substance-Based Medical Devices

Veronika Valdová
Vladimíra Štěpánová
Lenka Lapčíková

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1402684

3,871 views
3 citations

Original Research

Published on 06 Jan 2025

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

in Maternal-Fetal Medicine

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

9,076 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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

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

3,470 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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Jordi Mestres

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1497116

2,299 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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

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

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1428831

3,213 views
3 citations

Editorial

Published on 13 Nov 2024

Editorial: AI/ML in pharmacovigilance and pharmacoepidemiology

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Wen Zou
Pantelis Natsiavas
Assaf Gottlieb

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1517365

3,219 views
2 citations

Perspective

Published on 30 Oct 2024

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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Gerd Rippin
Héctor Sanz

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1409102

2,714 views
2 citations

Opinion

Published on 18 Sep 2024

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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Tarek A. Hammad
Sasan Sabrdaran
Jean-Marie Heim

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1477516

2,970 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

in Substance-Based Medical 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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

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”

in Vaccine Safety and Regulation

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

3,342 views

Original Research

Published on 19 Jul 2024

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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

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

5,616 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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

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

5,280 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

in Clinical Drug Safety

Takeshi Honma
Kenji Onda
Koichi Masuyama

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1334468

2,678 views
1 citation

Methods

Published on 11 Apr 2024

Application of the target trial emulation framework to external comparator studies

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Kellyn Arnold
Luis Antunes
Briana Coles
Hopin Lee

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1380568

5,946 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

in Substance-Based Medical Devices

Marcella Marletta

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1389406

2,798 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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

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

3,242 views
1 citation

Review

Published on 18 Mar 2024

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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

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

6,995 views
10 citations

Editorial

Published on 06 Feb 2024

Editorial: Traditional and innovative approaches for signal detection

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Marco Tuccori
Andrew Bate
Ugo Moretti
Gianluca Trifirò

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1373689

2,092 views

Editorial

Published on 05 Feb 2024

Editorial: Treatment of comorbidities of asthma and its safety

in Clinical Drug Safety

Serghei Covantsev
Alexandru Corlateanu

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1366847

1,453 views

100 articles

articles

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

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

Implementing tokenization in clinical research to expand real-world insights

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

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

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

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

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

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

Editorial: AI/ML in pharmacovigilance and pharmacoepidemiology

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

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

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

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

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

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

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

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

Application of the target trial emulation framework to external comparator studies

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

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

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

Editorial: Traditional and innovative approaches for signal detection

Editorial: Treatment of comorbidities of asthma and its safety