Frontiers in Drug Safety and Regulation

Perspective

Accepted on 24 Jan 2025

Tokenization implementation in clinical research to expand real-world insights

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Chelsea Walters
Crystal S Langlais
Eva E Oakkar
Wilhelmina E Hoogendoorn
James Coutcher
Mui Van Zandt

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1519307

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

in Substance-Based Medical Devices

Emiliano Giovagnoni
Luisa Mattoli
Andrea Cossu
Vitalia Murgia

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1519142

168 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

in Substance-Based Medical Devices

Veronika Valdová
Vladimíra Štěpánová
Lenka Lapčíková

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1402684

333 views

Original Research

Published on 06 Jan 2025

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

in Maternal-Fetal Medicine

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

264 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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

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

525 views

Original Research

Published on 06 Dec 2024

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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Jordi Mestres

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1497116

507 views

Mini Review

Published on 13 Nov 2024

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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

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

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1428831

438 views

Editorial

Published on 13 Nov 2024

Editorial: AI/ML in pharmacovigilance and pharmacoepidemiology

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Wen Zou
Pantelis Natsiavas
Assaf Gottlieb

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1517365

550 views

Perspective

Published on 30 Oct 2024

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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Gerd Rippin
Héctor Sanz

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1409102

635 views

Opinion

Published on 18 Sep 2024

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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Tarek A. Hammad
Sasan Sabrdaran
Jean-Marie Heim

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1477516

953 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

in Substance-Based Medical 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

570 views

Original Research

Published on 16 Aug 2024

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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Tarek A. Hammad
Simon Davis
Salman Afsar

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1445998

1,501 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”

in Vaccine Safety and Regulation

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

1,289 views

Original Research

Published on 19 Jul 2024

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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

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

2,472 views

Original Research

Published on 27 Jun 2024

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

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

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

1,625 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

in Rheumatic Drug Safety

Takeshi Honma
Kenji Onda
Koichi Masuyama

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1334468

846 views
1 citation

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Articles

Tokenization implementation in clinical research to expand real-world insights

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