Frontiers in Medicine | Regulatory Science

Original Research

Published on 12 Aug 2024

Toward trustworthy medical device in silico clinical trials: a hierarchical framework for establishing credibility and strategies for overcoming key challenges

in Regulatory Science

Kenneth I. Aycock
Tom Battisti
Ashley Peterson
Jiang Yao
Steven Kreuzer
Claudio Capelli
Sanjay Pant
Pras Pathmanathan
David M. Hoganson
Steve M. Levine

Frontiers in Medicine

doi 10.3389/fmed.2024.1433372

8,896 views
16 citations

Original Research

Published on 07 Aug 2024

In India, most principal investigators have run very few trials over the years

in Regulatory Science

Rishima Borah
Anwesha Dhal Samanta
Khujith Rajueni
Vina Vaswani
Gayatri Saberwal

Frontiers in Medicine

doi 10.3389/fmed.2024.1424570

3,799 views

Original Research

Published on 07 Aug 2024

Quality evaluation of selected expired fluoroquinolones medicines obtained from the public hospitals in Jimma zone, Oromia regional state, Ethiopia

in Regulatory Science

Habtamu Getahun
Sileshi Belew
Gemmechu Hasen
Guta Tefera
Yesuneh Tefera Mekasha
Sultan Suleman

Frontiers in Medicine

doi 10.3389/fmed.2024.1420146

4,376 views
1 citation

Review

Published on 07 Aug 2024

The future of medicine: an outline attempt using state-of-the-art business and scientific trends

in Regulatory Science

Gregorios Agyralides

Frontiers in Medicine

doi 10.3389/fmed.2024.1391727

4,086 views
3 citations

Opinion

Published on 01 Aug 2024

Experiences and challenges for EQA providers in assessing the commutability of control materials in accuracy-based EQA programs

in Regulatory Science

Laura Vierbaum
Patricia Kaiser
Michael Spannagl
Folker Wenzel
Mario Thevis
Ingo Schellenberg

Frontiers in Medicine

doi 10.3389/fmed.2024.1416642

1,629 views

Original Research

Published on 31 Jul 2024

Shared decision-making implementation status among dermatologists engaging in medical esthetics: a cross-sectional study in China

in Regulatory Science

Shiyuan Li
Jing Fan
Yan Qiang
Zhen Duan
Ruiping Wang

Frontiers in Medicine

doi 10.3389/fmed.2024.1418917

1,521 views
1 citation

Original Research

Published on 31 Jul 2024

More than red tape: exploring complexity in medical device regulatory affairs

in Regulatory Science

Yu Han
Aaron Ceross
Jeroen Bergmann

Frontiers in Medicine

doi 10.3389/fmed.2024.1415319

6,607 views
6 citations

Original Research

Published on 30 Jul 2024

A scalable and transparent data pipeline for AI-enabled health data ecosystems

in Regulatory Science

Tuncay Namli
Ali Anıl Sınacı
Suat Gönül
Cristina Ruiz Herguido
Patricia Garcia-Canadilla
Adriana Modrego Muñoz
Arnau Valls Esteve
Gökçe Banu Laleci Ertürkmen

Frontiers in Medicine

doi 10.3389/fmed.2024.1393123

3,484 views
8 citations

Perspective

Published on 29 Jul 2024

Drug repurposing in Rett and Rett-like syndromes: a promising yet underrated opportunity?

in Regulatory Science

Claudia Fuchs
Peter A. C. ‘t Hoen
Annelieke R. Müller
Friederike Ehrhart
Clara D. M. Van Karnebeek

Frontiers in Medicine

doi 10.3389/fmed.2024.1425038

3,801 views
2 citations

Systematic Review

Published on 18 Jul 2024

The impact of global falsified medicines regulation on healthcare stakeholders in the legitimate pharmaceutical supply chain: a systematic review

in Regulatory Science

Ellen Melia
Aislinn English
Bernard D. Naughton

Frontiers in Medicine

doi 10.3389/fmed.2024.1429872

4,253 views

Original Research

Published on 17 Jul 2024

Assessing the credibility of a drug’s effects: identification and judgment of uncertainty by the Dutch Medicines Evaluation Board

in Regulatory Science

Joyce M. Hoek
Jonna Brenninkmeijer
Ymkje Anna de Vries
Rob R. Meijer
Don van Ravenzwaaij

Frontiers in Medicine

doi 10.3389/fmed.2024.1409259

1,641 views
1 citation

Perspective

Published on 17 Jul 2024

Integrity at stake: confronting “publish or perish” in the developing world and emerging economies

in Regulatory Science

Jorge Vasconez-Gonzalez
Juan S. Izquierdo-Condoy
Patricio Naranjo-Lara
Miguel Ángel Garcia-Bereguiain
Esteban Ortiz-Prado

Frontiers in Medicine

doi 10.3389/fmed.2024.1405424

8,099 views
9 citations

Policy Brief

Published on 17 Jul 2024

Ethical framework for FACILITATE: a foundation for the return of clinical trial data to participants

in Regulatory Science

Ciara Staunton
Johanna M. C. Blom
Deborah Mascalzoni
on behalf of the IMI FACILITATE Consortium

Frontiers in Medicine

doi 10.3389/fmed.2024.1408600

2,108 views
1 citation

Original Research

Published on 16 Jul 2024

A reference architecture for personal health data spaces using decentralized content-addressable storage networks

in Regulatory Science

Toomas Klementi
Gunnar Piho
Peeter Ross

Frontiers in Medicine

doi 10.3389/fmed.2024.1411013

3,547 views
5 citations

Review

Published on 10 Jul 2024

A comprehensive analysis of digital health-focused Living Labs: innovative approaches to dementia

in Regulatory Science

Teodora Figueiredo
Luís Midão
Joana Carrilho
Diogo Videira Henriques
Sara Alves
Natália Duarte
Maria João Bessa
José María Fidalgo
Maria García
David Facal

Frontiers in Medicine

doi 10.3389/fmed.2024.1418612

3,014 views
3 citations

Original Research

Published on 05 Jul 2024

Three levels of discrepancies in the records of trial sites in India, registered with the European Union Clinical Trials Register

in Regulatory Science

Anwesha Dhal Samanta
Rishima Borah
Gayatri Saberwal

Frontiers in Medicine

doi 10.3389/fmed.2024.1357930

1,386 views
1 citation