Frontiers in Drug Safety and Regulation

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

1,827 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

3,437 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

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

2,663 views
4 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 Rheumatic Drug Safety

Takeshi Honma
Kenji Onda
Koichi Masuyama

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1334468

1,352 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

3,597 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

in Substance-Based Medical Devices

Marcella Marletta

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1389406

1,396 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

1,838 views

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

4,360 views
5 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

1,175 views

Editorial

Published on 05 Feb 2024

Editorial: Treatment of comorbidities of asthma and its safety

in Respiratory Drug Safety

Serghei Covantsev
Alexandru Corlateanu

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1366847

973 views

Perspective

Published on 02 Feb 2024

External comparators and estimands

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Gerd Rippin

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1332040

2,179 views
3 citations

Systematic Review

Published on 31 Jan 2024

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

in Vaccine Safety and Regulation

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

22,313 views
7 citations

Review

Published on 26 Jan 2024

Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

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

11,680 views
50 citations

Perspective

Published on 24 Jan 2024

External Comparator Cohort studies - clarification of terminology

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

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

3,106 views
4 citations

Review

Published on 21 Dec 2023

A review of the prescribing culture of anti-depressants across government districts in Northern Ireland

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Mark W. Ruddock
Joanne Watt
Mary Jo Kurth
John V. Lamont
Laura Mooney
Peter Fitzgerald

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1303572

2,244 views
2 citations

Review

Published on 14 Dec 2023

Safety of corticosteroid therapy in sarcoidosis treatment

in Respiratory Drug Safety

Alessandro Di Marco Berardino
Federico Mei
Lina Zuccatosta

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1319931

1,600 views