volumes

Volume 3 - 2023

Mini Review

Published on 16 Feb 2023

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

Yun-Ting Huang
Craig McCarthy
Meghna Jani

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1117674

3,828 views
6 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

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

3,964 views
5 citations

Perspective

Published on 01 Feb 2023

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

Jeffery L. Painter
Raymond Kassekert
Andrew Bate

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1110498

6,394 views
10 citations

Volume 2 - 2022

Technology and Code

Published on 19 Jan 2023

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

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

3,522 views
5 citations

Original Research

Published on 09 Jan 2023

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

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

2,556 views

Review

Published on 23 Dec 2022

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

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

8,778 views
18 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?

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

5,253 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

Roberto Cioeta
Andrea Cossu
Emiliano Giovagnoni
Marta Rigoni
Paola Muti

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.992359

6,852 views
11 citations

Perspective

Published on 07 Dec 2022

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

Guido Rasi
Alessandro Mugelli

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1071620

4,715 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

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

3,086 views
7 citations

Brief Research Report

Published on 10 Nov 2022

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

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

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1021068

3,329 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

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

1,625 views

Correction

Published on 26 Oct 2022

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

Emiliano Giovagnoni

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1054972

1,378 views

Brief Research Report

Published on 25 Oct 2022

Riluzole use in presence of contraindications in adults affected by amyotrophic lateral sclerosis and its off-label use in other motor neuron diseases: Findings from an Italian multicentre study (the CAESAR project)

Giada Crescioli
Marco Finocchietti
Silvia Cascini
Olga Paoletti
David Franchini
Emiliano Cappello
Giulia Valdiserra
Francesco Sciancalepore
Maria Grazia Celani
Marco Tuccori

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1041275

4,243 views
5 citations

Original Research

Published on 19 Oct 2022

Putting external validation performance of major bleeding risk models into context

Clair Blacketer
Jenna M. Reps
Lu Wang
Patrick B. Ryan
Zhong Yuan

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1034677

1,349 views

Original Research

Published on 10 Oct 2022

Effectiveness and tolerability of Poliprotect, a natural mucosal protective agent for gastroesophageal reflux disease and dyspepsia: Surveys from patients, physicians, and pharmacists

Roberto Cioeta
Paola Muti
Marta Rigoni
Luigi Morlando
Filippo Siragusa
Andrea Cossu
Emiliano Giovagnoni

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.969831

7,825 views
9 citations

Perspective

Published on 16 Sep 2022

New regulation on medical devices made of substances: Opportunities and challenges for pharmacological and toxicological research

Carmela Fimognari
Enrique Barrajón-Catalán
Cristina Luceri
Eleonora Turrini
Emanuel Raschi
Elisabetta Bigagli

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1001614

2,828 views
5 citations

Perspective

Published on 02 Sep 2022

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

Emiliano Giovagnoni

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.998114

5,122 views
7 citations

Opinion

Published on 15 Aug 2022

Towards a European harmonization of health technology assessment recommendations executive paper of European regulatory conference focused on the EU commission proposal to harmonize HTA

Lucia Gozzo
Kenneth Paterson
Olivier Wong
Francis Megerlin
Jan Geldmacher
Patrizia Popoli
Claudio Jommi
Frank-Ulrich Fricke
Oriol De Solà-Morales
Isao Kamae

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.970661

3,615 views
11 citations

Perspective

Published on 04 Jul 2022

Medical Devices Made of Substances: A New Challenge

Maria Grazia Leone

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.952013

7,960 views
6 citations

Perspective

Published on 28 Jun 2022

Medical Devices Made of Substances: The Need for a Change in Approach in Paediatrics

Stefano Stagi

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.867143

4,253 views
2 citations

Mini Review

Published on 27 Jun 2022

Pharmacological Versus Non-Pharmacological and Ancillary Mechanisms in Eye Drops Used in the Treatment of Glaucoma

Nicoletta Marchesi
Foroogh Fahmideh
Annalisa Barbieri
Marco Racchi
Alessia Pascale
Stefano Govoni

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.933471

3,779 views
2 citations

Brief Research Report

Published on 15 Jun 2022

Increased Confidence in Deduplication of Drug Safety Reports with Natural Language Processing of Narratives at the US Food and Drug Administration

Kory Kreimeyer
Oanh Dang
Jonathan Spiker
Paula Gish
Jessica Weintraub
Eileen Wu
Robert Ball
Taxiarchis Botsis

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.918897

4,847 views
9 citations

Mini Review

Published on 08 Jun 2022

Digital Therapeutics in Perspective: From Regulatory Challenges to Post-Marketing Surveillance

Salvatore Crisafulli
Eugenio Santoro
Giuseppe Recchia
Gianluca Trifirò

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.900946

11,459 views
30 citations