Frontiers in Drug Safety and Regulation

Volume 4 - 2024

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

1,444 views
1 citation

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

2,109 views
2 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

2,043 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

3,787 views
1 citation

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

3,076 views
5 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

1,514 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

3,863 views
3 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

1,562 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

2,033 views

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

4,774 views
5 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

1,263 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

1,031 views

Systematic Review

Published on 31 Jan 2024

Menstrual disorders following COVID-19 vaccination: a review using a systematic search

Veerle R. Smaardijk
Rana Jajou
Agnes Kant
Florence P. A. M. van Hunsel

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1338466

24,927 views
8 citations

Volume 3 - 2023

Perspective

Published on 02 Feb 2024

External comparators and estimands

Gerd Rippin

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1332040

2,323 views
3 citations

Review

Published on 26 Jan 2024

Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems

Paola Maria Cutroneo
Daniele Sartori
Marco Tuccori
Salvatore Crisafulli
Vera Battini
Carla Carnovale
Concetta Rafaniello
Annalisa Capuano
Elisabetta Poluzzi
Ugo Moretti

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1323057

12,857 views
56 citations

Perspective

Published on 24 Jan 2024

External Comparator Cohort studies - clarification of terminology

Gerd Rippin
Joan Largent
Wilhelmina Elisabeth Hoogendoorn
Héctor Sanz
Jaclyn Bosco
Christina Mack

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1321894

3,325 views
4 citations