Review

Accepted on 22 Nov 2024

Important Tool in Our Rare Disease Toolbox: Hybrid Retrospective-Prospective Natural History Studies Serve Well as External Comparators for Rare Disease Studies Target Journal: Frontiers (review max 12,000)

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

Original Research

Accepted on 19 Nov 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

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

161 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

205 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

405 views

Case Report

Accepted on 28 Oct 2024

A case report:Interstitial pneumonia following treatment of gastric cancer with Sintilimab in combination with S-1

Pei Zhu
Qingming Sun
Sheng Xu
Wanhui Dong

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1508558

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

704 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

371 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

1,232 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

1,080 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

2,089 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

1,307 views

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

685 views

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

2,069 views
1 citation

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

Marcella Marletta

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1389406

754 views

Original Research

Published on 20 Mar 2024

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

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

1,053 views

Navigation group

Volumes

Important Tool in Our Rare Disease Toolbox: Hybrid Retrospective-Prospective Natural History Studies Serve Well as External Comparators for Rare Disease Studies Target Journal: Frontiers (review max 12,000)

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

A case report:Interstitial pneumonia following treatment of gastric cancer with Sintilimab in combination with S-1

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

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