Frontiers in Drug Safety and Regulation

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

doi 10.3389/fdsfr.2022.1016042

3,518 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

2,553 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

8,765 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

6,843 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

3,080 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

3,324 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

4,230 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

1,346 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

7,816 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

2,826 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

7,955 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

3,778 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

4,846 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

11,457 views
30 citations

Systematic Review

Published on 24 May 2022

Efficacy and Safety of a Polysaccharide-Based Natural Substance Complex in the Treatment of Obesity and Other Metabolic Syndrome Components: A Systematic Review

Giuseppina Guarino
Felice Strollo
Peter Malfertheiner
Teresa Della Corte
Stefano Stagi
Mario Masarone
Sandro Gentile

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.844256

4,667 views
9 citations

Specialty Grand Challenge

Published on 05 Apr 2022

Current Status and Future Challenges in the Treatment of Rheumatic Diseases

Enrique R. Soriano

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.881556

4,970 views
7 citations

Field Grand Challenge

Published on 25 Feb 2022

A New Era of Pharmacovigilance: Future Challenges and Opportunities

Gianluca Trifirò
Salvatore Crisafulli

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.866898

44,442 views
57 citations

24 Publications

volumes

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

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

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

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

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

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

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

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

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

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

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)

Putting external validation performance of major bleeding risk models into context

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

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

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

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

Medical Devices Made of Substances: A New Challenge

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

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

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

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

Efficacy and Safety of a Polysaccharide-Based Natural Substance Complex in the Treatment of Obesity and Other Metabolic Syndrome Components: A Systematic Review

Current Status and Future Challenges in the Treatment of Rheumatic Diseases

A New Era of Pharmacovigilance: Future Challenges and Opportunities