Regulatory Assessment | List of Frontiers open access articles

Review

Published on 09 Apr 2024

New approach methodologies to enhance human health risk assessment of immunotoxic properties of chemicals — a PARC (Partnership for the Assessment of Risk from Chemicals) project

in Immunotoxicology

Igor Snapkow
Nicola M. Smith
Emma Arnesdotter
Karsten Beekmann
Etienne B. Blanc
Albert Braeuning
Emanuela Corsini
Marija Sollner Dolenc
Loes P. M. Duivenvoorde
Gunnar Sundstøl Eriksen

Frontiers in Toxicology

doi 10.3389/ftox.2024.1339104

8,658 views
14 citations

Policy and Practice Reviews

Published on 02 Mar 2023

Regulatory assessment of nano-enabled health products in public health interest. Position of the scientific advisory board of the French National Agency for the Safety of Medicines and Health Products

in Public Health Policy

Wahiba Oualikene-Gonin
Valérie Sautou
Eric Ezan
Henri Bastos
Eric Bellissant
Laëtitia Belgodère
Patrick Maison
Joël Ankri
The Scientific Advisory Board of the ANSM
Joël Ankri

Frontiers in Public Health

doi 10.3389/fpubh.2023.1125577

6,599 views
46 citations

Perspective

Published on 23 Feb 2023

Use of National Database of Health Insurance Claims and Specific Health Checkups for examining practical utilization and safety signal of a drug to support regulatory assessment on postmarketing drug safety in Japan

in Regulatory Science

Haruka Shida
Kazuhiro Kajiyama
Sono Sawada
Chieko Ishiguro
Mikiko Kubo
Ryota Kimura
Mai Hirano
Noriyuki Komiyama
Toyotaka Iguchi
Yukio Oniyama

Frontiers in Medicine

doi 10.3389/fmed.2023.1096992

6,303 views
7 citations

Original Research

Published on 25 Nov 2022

Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the member countries

in Drugs Outcomes Research and Policies

Mercy Owusu-Asante
Delese Mimi Darko
Stuart Walker
Sam Salek

Frontiers in Pharmacology

doi 10.3389/fphar.2022.1069345

4,939 views
8 citations

Original Research

Published on 24 Dec 2024

An Adverse Outcome Pathway for food nanomaterial-induced intestinal barrier disruption

in Computational Toxicology and Informatics

Deborah Stanco
Dorelia Lipsa
Alessia Bogni
Susanne Bremer-Hoffmann
Laure-Alix Clerbaux

Frontiers in Toxicology

doi 10.3389/ftox.2024.1474397

2,614 views
1 citation

Policy and Practice Reviews

Published on 10 Feb 2025

From guideline to practice: three years of ICH S11 insights and recommendations

in Regulatory Science

Diana Tavares
Hsiao-Tzu Chien
Maria Elzbieta Sheean
Peter Theunissen
Peter van Meer
Karen Van Malderen

Frontiers in Medicine

doi 10.3389/fmed.2025.1537001

5,969 views

Original Research

Published on 09 Jun 2023

The herbicides glyphosate and glufosinate and the cyanotoxin β-N-methylamino-l-alanine induce long-term motor disorders following postnatal exposure: the importance of prior asymptomatic maternal inflammatory sensitization

in Neurodevelopment

Asma Oummadi
Arnaud Menuet
Sarah Méresse
Anthony Laugeray
Gilles Guillemin
Stéphane Mortaud

Frontiers in Neuroscience

doi 10.3389/fnins.2023.1172693

4,010 views
3 citations

Original Research

Published on 23 Aug 2017

Optimization of an In silico Cardiac Cell Model for Proarrhythmia Risk Assessment

in Computational Physiology and Medicine

Sara Dutta
Kelly C. Chang
Kylie A. Beattie
Jiansong Sheng
Phu N. Tran
Wendy W. Wu
Min Wu
David G. Strauss
Thomas Colatsky
Zhihua Li

Frontiers in Physiology

doi 10.3389/fphys.2017.00616

15,299 views
185 citations

Original Research

Published on 28 Sep 2023

Parameters, practices, and preferences for regulatory review of emerging biotechnology products in food and agriculture

in Biosafety and Biosecurity

Jennifer Kuzma
Khara Grieger
Ilaria Cimadori
Christopher L. Cummings
Nick Loschin
Wei Wei

Frontiers in Bioengineering and Biotechnology

doi 10.3389/fbioe.2023.1256388

7,319 views
15 citations

Original Research

Published on 16 Aug 2023

How can patient preferences be used and communicated in the regulatory evaluation of medicinal products? Findings and recommendations from IMI PREFER and call to action

in Drugs Outcomes Research and Policies

Rosanne Janssens
Liese Barbier
Mireille Muller
Irina Cleemput
Isabelle Stoeckert
Chiara Whichello
Bennett Levitan
Tarek A. Hammad
Charis Girvalaki
Juan-Jose Ventura

Frontiers in Pharmacology

doi 10.3389/fphar.2023.1192770

7,577 views
18 citations

Articles

New approach methodologies to enhance human health risk assessment of immunotoxic properties of chemicals — a PARC (Partnership for the Assessment of Risk from Chemicals) project

Regulatory assessment of nano-enabled health products in public health interest. Position of the scientific advisory board of the French National Agency for the Safety of Medicines and Health Products

Use of National Database of Health Insurance Claims and Specific Health Checkups for examining practical utilization and safety signal of a drug to support regulatory assessment on postmarketing drug safety in Japan

Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the member countries

An Adverse Outcome Pathway for food nanomaterial-induced intestinal barrier disruption

From guideline to practice: three years of ICH S11 insights and recommendations

The herbicides glyphosate and glufosinate and the cyanotoxin β-N-methylamino-l-alanine induce long-term motor disorders following postnatal exposure: the importance of prior asymptomatic maternal inflammatory sensitization

Optimization of an In silico Cardiac Cell Model for Proarrhythmia Risk Assessment

Parameters, practices, and preferences for regulatory review of emerging biotechnology products in food and agriculture

How can patient preferences be used and communicated in the regulatory evaluation of medicinal products? Findings and recommendations from IMI PREFER and call to action