Frontiers in Drug Safety and Regulation

Methods

Published on 11 Apr 2023

Safety and efficacy of substance-based medical devices: Design of an in vitro barrier effect test

in Substance-Based Medical Devices

Rebecca Bassetto
Stefano Perin
Emanuele Amadio
Samuele Zanatta
Davide Nenzioni
Walter Bertin

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1124873

1,719 views
1 citation

Specialty Grand Challenge

Published on 31 Mar 2023

Specialty grand challenge editorial innovative approaches for pharmacoepidemiologic research in pregnancy: Shifting the paradigm of Thalidomide’s impact on pregnant women

in Maternal-Fetal Medicine

Eva Gerbier
Alice Panchaud

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1187070

2,119 views
3 citations

Review

Published on 24 Feb 2023

Gastrointestinal functional disorders can benefit from the use of medical devices made of substances

in Substance-Based Medical Devices

Vincenzo Savarino
Elisa Marabotto
Patrizia Zentilin
Manuele Furnari
Giorgia Bodini
Edoardo Giovanni Giannini
Edoardo Vincenzo Savarino

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1119353

1,577 views
2 citations

Mini Review

Published on 16 Feb 2023

Balancing the evidence: An update on analgesic use in rheumatic and musculoskeletal diseases

in Rheumatic Drug Safety

Yun-Ting Huang
Craig McCarthy
Meghna Jani

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1117674

2,287 views
2 citations

Original Research

Published on 07 Feb 2023

Natural language processing for automated triage and prioritization of individual case safety reports for case-by-case assessment

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Thomas Lieber
Helen R. Gosselt
Pelle C. Kools
Okko C. Kruijssen
Stijn N. C. Van Lierop
Linda Härmark
Florence P. A. M. Van Hunsel

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1120135

2,444 views
2 citations

Perspective

Published on 01 Feb 2023

An industry perspective on the use of machine learning in drug and vaccine safety

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Jeffery L. Painter
Raymond Kassekert
Andrew Bate

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1110498

4,483 views
9 citations

Technology and Code

Published on 19 Jan 2023

An open-source platform integrating emerging data sources to support multi-modal active pharmacovigilance

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Vlasios K. Dimitriadis
Stella Dimitsaki
Achilleas Chytas
George I. Gavriilidis
Christine Kakalou
Panos Bonotis
Pantelis Natsiavas

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1016042

2,333 views
4 citations

Original Research

Published on 09 Jan 2023

Adverse events in rheumatoid arthritis patients under antimalarial treatment—Is there cardiovascular compromise?

in Rheumatic Drug Safety

Pedro Santos-Moreno
Linda Ibatá
Susan Martínez
Gabriel-Santiago Rodríguez-Vargas
Laura Villarreal
Pedro Rodríguez
Wilberto Rivero
Fernando Rodríguez-Florido
Adriana Rojas-Villarraga

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1044696

1,734 views

Review

Published on 23 Dec 2022

Deprescribing as a strategy for improving safety of medicines in older people: Clinical and regulatory perspective

in Cardiovascular Drug Safety

Salvatore Crisafulli
Elisabetta Poluzzi
Carlotta Lunghi
Vincenzo Di Francesco
Luca Pellizzari
Luca Pasina
Chiara Elli
Francesco Trotta
Agnese Cangini
Caterina Trevisan

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1011701

5,519 views
11 citations

Policy and Practice Reviews

Published on 15 Dec 2022

Medicinal products, medical devices, or accessories of medical devices: How to qualify gases for spirometry?

in Substance-Based Medical Devices

Sara Manellari
Maria Grazia Leone
Antonella Casiraghi
Chiara Grazia Milena Gennari
Paola Minghetti

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1089965

4,058 views
2 citations

Protocols

Published on 09 Dec 2022

A new platform for post-marketing surveillance and real-world evidence data collection for substance-based medical devices

in Substance-Based Medical Devices

Roberto Cioeta
Andrea Cossu
Emiliano Giovagnoni
Marta Rigoni
Paola Muti

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.992359

4,926 views
8 citations

Perspective

Published on 07 Dec 2022

European Union Regulation on clinical trials and Regulation on medical devices: A common soil for future development

in Substance-Based Medical Devices

Guido Rasi
Alessandro Mugelli

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1071620

3,797 views
1 citation

Brief Research Report

Published on 14 Nov 2022

Evaluation of a natural language processing tool for extracting gender, weight, ethnicity, and race in the US food and drug administration adverse event reporting system

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Vivian Dang
Eileen Wu
Cindy M. Kortepeter
Michael Phan
Rongmei Zhang
Yong Ma
Monica A. Muñoz

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1020943

1,824 views
4 citations

Brief Research Report

Published on 10 Nov 2022

Exploring opportunities for AI supported medication error categorization: A brief report in human machine collaboration

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Allan Fong
Christopher Bonk
Varvara Vasilchenko
Suranjan De
Douglas Kovich
Jo Wyeth

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1021068

2,019 views
1 citation

Opinion

Published on 26 Oct 2022

Establishing patient safety monitoring in the benefit-risk paradigm for off-label and emergency use of medications for COVID-19: A pharmacovigilance perspective

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Marina A. Malikova
Gianluca Trifirò
Giorgio Racagni
Dennis Van Liew
Peggy Webster
Tejal S. Brahmbhatt

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1038235

1,095 views

Correction

Published on 26 Oct 2022

Corrigendum: Substance-based medical devices made of natural substances: An opportunity for therapeutic innovation

in Substance-Based Medical Devices

Emiliano Giovagnoni

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1054972

915 views