Frontiers in Drug Safety and Regulation

Review

Published on 17 Jan 2025

Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare

Emiliano Giovagnoni
Luisa Mattoli
Andrea Cossu
Vitalia Murgia

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1519142

224 views

Original Research

Published on 16 Jan 2025

The safety and efficacy of neutral electrolyzed water solution for wound irrigation: post-market clinical follow-up study

Veronika Valdová
Vladimíra Štěpánová
Lenka Lapčíková

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1402684

373 views

Original Research

Published on 06 Jan 2025

Detection of nontoxic BoNT/A levels in post-facial Botox injection breastmilk

Helene Gu
Zhenyu Xu
Renata Koviazina
Pengcheng Tan
Changcheng Zheng
Ferdinand Kappes
Domna G. Kotsifaki
Fangrong Shen
Anastasia Tsigkou

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1480515

312 views

Review

Published on 18 Dec 2024

Important tool in our rare disease toolbox: hybrid retrospective-prospective natural history studies serve well as external comparators for rare disease studies

Chinenye Ugoji
Julien Heidt
Joan Largent
Emily Bratton
Laura Hester
Sareh Keshavarzi
Stuart Turner
Christina Mack

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1418050

569 views

Original Research

Published on 06 Dec 2024

Influence of differential source patterns in the detection of signals of disproportionate reporting for PARP inhibitors

Jordi Mestres

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1497116

535 views

Mini Review

Published on 13 Nov 2024

Integrating electronic health records with other data sources for postmarket drug safety signal identification: a review

Julie V. Kim
Sharon E. Davis
Michael E. Matheny
Joshua C. Smith

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1428831

484 views

Editorial

Published on 13 Nov 2024

Editorial: AI/ML in pharmacovigilance and pharmacoepidemiology

Wen Zou
Pantelis Natsiavas
Assaf Gottlieb

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1517365

588 views

Perspective

Published on 30 Oct 2024

External comparator studies and the joint application of the estimand and target trial emulation frameworks

Gerd Rippin
Héctor Sanz

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1409102

672 views

Opinion

Published on 18 Sep 2024

Achieving synchrony: bridging the gap between pharmaceutical companies and regulators on safety labeling updates

Tarek A. Hammad
Sasan Sabrdaran
Jean-Marie Heim

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1477516

995 views

Original Research

Published on 17 Sep 2024

Demonstrating the principal mechanism of action of medical devices intended for vaginal use on reconstructed human vaginal epithelium: the case of two hyaluronic acid-containing devices

Marisa Meloni
Barbara De Servi
Francesco Carriero
Emmanuelle Simon O’Brien
Dounia Houamel
Philippe Deruelle
Vincent Castagné

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1445519

589 views

Original Research

Published on 16 Aug 2024

Exploring the scientific underpinnings of investigating safety signals: analytical insights in deciphering drug safety evidence

Tarek A. Hammad
Simon Davis
Salman Afsar

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1445998

1,526 views
1 citation

Original Research

Published on 12 Aug 2024

Cohort event monitoring of safety of COVID-19 vaccines: the Italian experience of the “ilmiovaccinoCOVID19 collaborating group”

Nicoletta Luxi
Chiara Bellitto
Francesco Ciccimarra
Emiliano Cappello
Luca L’Abbate
Marco Bonaso
Chiara Ajolfi
Paolo Baldo
Roberto Bonaiuti
Claudio Costantino

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1363086

1,316 views

Original Research

Published on 19 Jul 2024

Measurement error and bias in real-world oncology endpoints when constructing external control arms

Benjamin Ackerman
Ryan W. Gan
Craig S. Meyer
Jocelyn R. Wang
Youyi Zhang
Jennifer Hayden
Grace Mahoney
Jennifer L. Lund
Janick Weberpals
Sebastian Schneeweiss

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1423493

2,528 views

Original Research

Published on 27 Jun 2024

Assessing the performance of large language models in literature screening for pharmacovigilance: a comparative study

Dan Li
Leihong Wu
Mingfeng Zhang
Svitlana Shpyleva
Ying-Chi Lin
Ho-Yin Huang
Ting Li
Joshua Xu

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1379260

1,678 views
1 citation

Original Research

Published on 13 May 2024

Progressive multifocal leukoencephalopathy reports in rheumatoid arthritis concerning different treatment patterns-an exploratory assessment using the food and drug administration adverse event reporting system

Takeshi Honma
Kenji Onda
Koichi Masuyama

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1334468

861 views
1 citation

Methods

Published on 11 Apr 2024

Application of the target trial emulation framework to external comparator studies

Kellyn Arnold
Luis Antunes
Briana Coles
Hopin Lee

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1380568

2,529 views
1 citation

Navigation group

Volumes

Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare

The safety and efficacy of neutral electrolyzed water solution for wound irrigation: post-market clinical follow-up study

Detection of nontoxic BoNT/A levels in post-facial Botox injection breastmilk

Important tool in our rare disease toolbox: hybrid retrospective-prospective natural history studies serve well as external comparators for rare disease studies

Influence of differential source patterns in the detection of signals of disproportionate reporting for PARP inhibitors

Integrating electronic health records with other data sources for postmarket drug safety signal identification: a review

Editorial: AI/ML in pharmacovigilance and pharmacoepidemiology

External comparator studies and the joint application of the estimand and target trial emulation frameworks

Achieving synchrony: bridging the gap between pharmaceutical companies and regulators on safety labeling updates

Demonstrating the principal mechanism of action of medical devices intended for vaginal use on reconstructed human vaginal epithelium: the case of two hyaluronic acid-containing devices

Exploring the scientific underpinnings of investigating safety signals: analytical insights in deciphering drug safety evidence

Cohort event monitoring of safety of COVID-19 vaccines: the Italian experience of the “ilmiovaccinoCOVID19 collaborating group”

Measurement error and bias in real-world oncology endpoints when constructing external control arms

Assessing the performance of large language models in literature screening for pharmacovigilance: a comparative study

Progressive multifocal leukoencephalopathy reports in rheumatoid arthritis concerning different treatment patterns-an exploratory assessment using the food and drug administration adverse event reporting system

Application of the target trial emulation framework to external comparator studies