Frontiers in Drug Safety and Regulation | Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Original Research

Accepted on 19 Dec 2025

Hepatobiliary Adverse Drug Reactions during treatment with olaparib: an analysis of data from the EudraVigilance reporting system

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Elena–Mirabela Velișcu
Cecilia Cagnotta
Maria Giuseppa Sullo
Antonietta Anatriello
Francesco Salvo
Cristina Scavone

Frontiers in Drug Safety and Regulation

169 views

Mini Review

Published on 18 Dec 2025

Tokenization techniques for privacy-preserving healthcare data: tokenization nuts and bolts

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Camille V. Cook

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1599217

1,067 views

Correction

Published on 07 Nov 2025

Correction: Leveraging real-world data for safety signal detection and risk management in pre- and post-market settings

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Kathleen M. Gavin
Matthew L. Sundermann
Alethea Wieland

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1729828

950 views

Perspective

Published on 17 Oct 2025

Leveraging real-world data for safety signal detection and risk management in pre- and post-market settings

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Kathleen M. Gavin
Matthew L. Sundermann
Alethea Wieland

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1626822

3,713 views

Opinion

Published on 16 Sep 2025

Rethinking drug safety signal detection and causality assessment in the age of AI: the risks of incomplete data and biased insights

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Priyanka Chhikara
Tarek A. Hammad

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1678074

3,426 views
1 citation

Original Research

Published on 10 Sep 2025

Identifying regulatory outcomes of Non-interventional Post-Authorisation Safety Studies (PASS) in the European repository of studies using publicly available information

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

M. F. Almas
A. Girardi
S. Crisafulli
K. Gvozdanovic
K. M. Hakkarainen
G. Hyeraci
W. E. Hoogendoorn
B. Rillmann
G. Roberto
G. Vitturi

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1574430

2,084 views

Review

Published on 20 Jun 2025

Centralized daily drug management in clinical trial institutions and specific implementation plans

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Yu Tang
Xiaolong Fang

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1620314

2,045 views

Editorial

Published on 11 Mar 2025

Editorial: External control arms for single-arm studies: methodological considerations and applications

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Deborah Layton
Laura Hester
Asieh Golozar

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1579171

2,574 views

Perspective

Published on 13 Feb 2025

Implementing tokenization 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 B. Coutcher
Mui Van Zandt

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1519307

4,537 views
1 citation

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

3,470 views
2 citations

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

2,299 views
1 citation

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

3,213 views
3 citations

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

3,219 views
2 citations

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

2,714 views
2 citations

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

2,970 views
2 citations

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

3,131 views
3 citations

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

5,616 views
3 citations

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

5,280 views
7 citations

Methods

Published on 11 Apr 2024

Application of the target trial emulation framework to external comparator studies

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Kellyn Arnold
Luis Antunes
Briana Coles
Hopin Lee

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1380568

5,946 views
4 citations

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

3,242 views
1 citation

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

6,995 views
10 citations

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

2,092 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

3,228 views
5 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

18,597 views
96 citations

43 articles

articles

Hepatobiliary Adverse Drug Reactions during treatment with olaparib: an analysis of data from the EudraVigilance reporting system

Tokenization techniques for privacy-preserving healthcare data: tokenization nuts and bolts

Correction: Leveraging real-world data for safety signal detection and risk management in pre- and post-market settings

Leveraging real-world data for safety signal detection and risk management in pre- and post-market settings

Rethinking drug safety signal detection and causality assessment in the age of AI: the risks of incomplete data and biased insights

Identifying regulatory outcomes of Non-interventional Post-Authorisation Safety Studies (PASS) in the European repository of studies using publicly available information

Centralized daily drug management in clinical trial institutions and specific implementation plans

Editorial: External control arms for single-arm studies: methodological considerations and applications

Implementing tokenization in clinical research to expand real-world insights

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

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

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

Application of the target trial emulation framework to external comparator studies

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

External comparators and estimands

Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems