Frontiers in Drug Safety and Regulation

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

3,275 views
2 citations

Original Research

Published on 25 Aug 2023

The risk of preterm labor after COVID-19 vaccination before and during pregnancy

in Maternal-Fetal Medicine

M. de Feijter
L. C. M. Vissers
L. Davidson
A. C. Kant
P. J. Woestenberg

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1235051

2,062 views
3 citations

Review

Published on 04 Aug 2023

Mucoadhesive polymers in substance-based medical devices: functional ingredients or what else?

in Substance-Based Medical Devices

Barbara Vigani
Silvia Rossi
Giuseppina Sandri
Maria Cristina Bonferoni
Carla M. Caramella

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1227763

4,598 views
5 citations

Original Research

Published on 04 Aug 2023

Evaluation of cardiovascular toxicity of the atezolizumab and bevacizumab combination

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Takahiro Niimura
Mitsuhiro Goda
Koji Miyata
Jun Matsumoto
Toshihiko Yoshioka
Hirofumi Hamano
Fuka Aizawa
Kenta Yagi
Yuki Izawa-Ishizawa
Yoshito Zamami

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1213771

1,778 views

Original Research

Published on 17 Jul 2023

Signal management and risk minimization strategy: a case study on obinutuzumab and non-overt disseminated intravascular coagulation

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Giulia Valdiserra
Nadia Mores
Rosalba Elisabetta Rocchi
Laura Sottosanti
Patrizia Felicetti
Pasquale Marchione
Luca Laurenti
Alberto Fresa
Giampaolo Bucaneve
Emiliano Cappello

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1194683

1,141 views
1 citation

Methods

Published on 29 Jun 2023

Elements to assess the quality of information of case reports in pregnancy pharmacovigilance data—a ConcePTION project

in Maternal-Fetal Medicine

Yrea R. J. van Rijt-Weetink
Khoezik Chamani
Antoine C. G. Egberts
Florence P. A. M. van Hunsel
David J. Lewis
Laura M. Yates
Ursula Winterfeld
Eugène P. van Puijenbroek

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1187888

1,998 views
3 citations

Editorial

Published on 31 May 2023

Editorial: Substance-based medical devices for human health: a challenge of efficacy, safety, and sustainability

in Substance-Based Medical Devices

Alessandro Mugelli
Juan Tamargo

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1222790

775 views

Methods

Published on 25 May 2023

Aspects to consider in causality assessment of safety signals: broadening the thought process

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Tarek A. Hammad
Salman Afsar
Laura B. McAvoy
Hervé Le Louet

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1193413

7,780 views
7 citations

Original Research

Published on 16 May 2023

Development and design of the BELpREG registration system for the collection of real-world data on medication use in pregnancy and mother-infant outcomes

in Maternal-Fetal Medicine

Laure Sillis
Veerle Foulon
Karel Allegaert
Annick Bogaerts
Maarten De Vos
Titia Hompes
Anne Smits
Kristel Van Calsteren
Jan Y. Verbakel
Michael Ceulemans

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1166963

2,512 views
2 citations

Original Research

Published on 04 May 2023

Datamama, bringing pregnancy research into the future: design, development, and evaluation of a citizen science pregnancy mobile application

in Maternal-Fetal Medicine

Eva Gerbier
Yvan Vial
Jardena Puder
Olivier Le Dizès
Magali Andrey
Amar Arhab
Antje Horsch
Valérie Avignon
Déborah Fort
Camille Deforges

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1187023

2,107 views
1 citation

Editorial

Published on 21 Apr 2023

Editorial: Computational methods and systems to support decision making in pharmacovigilance

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Taxiarchis Botsis
Robert Ball
G. Niklas Norén

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2023.1188715

1,089 views

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

1,444 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

1,753 views
2 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

1,252 views

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

1,907 views
1 citation

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

2,111 views
2 citations

Navigation group

Articles

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

The risk of preterm labor after COVID-19 vaccination before and during pregnancy

Mucoadhesive polymers in substance-based medical devices: functional ingredients or what else?

Evaluation of cardiovascular toxicity of the atezolizumab and bevacizumab combination

Signal management and risk minimization strategy: a case study on obinutuzumab and non-overt disseminated intravascular coagulation

Elements to assess the quality of information of case reports in pregnancy pharmacovigilance data—a ConcePTION project

Editorial: Substance-based medical devices for human health: a challenge of efficacy, safety, and sustainability

Aspects to consider in causality assessment of safety signals: broadening the thought process

Development and design of the BELpREG registration system for the collection of real-world data on medication use in pregnancy and mother-infant outcomes

Datamama, bringing pregnancy research into the future: design, development, and evaluation of a citizen science pregnancy mobile application

Editorial: Computational methods and systems to support decision making in pharmacovigilance

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

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

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

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

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