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

832 views

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

1,221 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

2,774 views
1 citation

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

842 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

764 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

1,502 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

11,758 views
3 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

6,969 views
21 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

2,193 views
1 citation

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

1,545 views
1 citation

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

1,034 views

Correction

Published on 04 Dec 2023

Corrigendum: 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.2023.1244115

528 views

Original Research

Published on 23 Nov 2023

Drug target, class level, and PathFX pathway information share utility for machine learning prediction of common drug-induced side effects

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Han Jie Liu
Jennifer L. Wilson

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1287535

1,132 views

Review

Published on 07 Nov 2023

Promising treatment biomarkers in asthma

in Respiratory Drug Safety

Barbara Bonnesen
Jens-Ulrik S. Jensen
Alexander G. Mathioudakis
Alexandru Corlateanu
Pradeesh Sivapalan

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1291471

1,592 views
1 citation

Original Research

Published on 15 Sep 2023

Identification of small cell lung cancer patients who are at risk of developing common serious adverse event groups with machine learning

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Linda Wanika
Neil D. Evans
Michael J. Chappell

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1267623

685 views

Methods

Published on 06 Sep 2023

Navigating a transforming landscape: the evolving role of pharmacovigilance physicians in drug development and implications for future challenges and training requirements

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Tarek A. Hammad
Salman Afsar
Herve Le-Louet
Veronique F. Kugener

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1257732

3,101 views
2 citations

Navigation group

Articles

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

Machine learning analysis of patients’ perceptions towards generic medication in Greece: a survey-based study

Artificial intelligence for optimizing benefits and minimizing risks of pharmacological therapies: challenges and opportunities

Editorial: Traditional and innovative approaches for signal detection

Editorial: Treatment of comorbidities of asthma and its safety

External comparators and estimands

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

Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems

External Comparator Cohort studies - clarification of terminology

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

Safety of corticosteroid therapy in sarcoidosis treatment

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

Drug target, class level, and PathFX pathway information share utility for machine learning prediction of common drug-induced side effects

Promising treatment biomarkers in asthma

Identification of small cell lung cancer patients who are at risk of developing common serious adverse event groups with machine learning

Navigating a transforming landscape: the evolving role of pharmacovigilance physicians in drug development and implications for future challenges and training requirements