Understanding and estimating the exposure to a substance is one of the fundamental requirements for safe manufacture and use. Many approaches are taken to determine exposure to substances, mainly driven by potential use and regulatory need. There are many opportunities to improve and optimise the use of exposure information for chemical safety. The European Partnership for Alternative Approaches to Animal Testing (EPAA) therefore convened a Partners' Forum (PF) to explore exposure considerations in human safety assessment of industrial products to agree key conclusions for the regulatory acceptance of exposure assessment approaches and priority areas for further research investment. The PF recognised the widescale use of exposure information across industrial sectors with the possibilities of creating synergies between different sectors. Further, the PF acknowledged that the EPAA could make a significant contribution to promote the use of exposure data in human safety assessment, with an aim to address specific regulatory needs. To achieve this, research needs, as well as synergies and areas for potential collaboration across sectors, were identified.

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.yrtph.2023.105483DOI Listing

Publication Analysis

Top Keywords

human safety
12
safety assessment
12
exposure
8
exposure considerations
8
considerations human
8
partners' forum
8
safety
4
assessment
4
assessment report
4
report epaa
4

Similar Publications

Beyond the Herald Patch: Exploring the Complex Landscape of Pityriasis Rosea.

Am J Clin Dermatol

January 2025

Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, 33136, USA.

Pityriasis rosea (PR) is a prevalent dermatological condition characterized by a distinctive herald patch, followed by secondary eruptions, often forming a "Christmas tree" pattern on the trunk. Despite its recognizable clinical presentation, the etiology of PR remains uncertain, with hypotheses pointing to both infectious and noninfectious origins. Human herpesviruses (HHV) 6 and 7 have been implicated, with evidence suggesting viral reactivation as a potential trigger.

View Article and Find Full Text PDF

Impact of backpack load during walking: an EMG and biomechanical analysis.

Med Biol Eng Comput

January 2025

Biomedical Engineering, Bahçeşehir University, Çırağan Caddesi Osmanpaşa Mektebi Sokak No: 4-6 Beşiktaş, İstanbul, 34353, Turkey.

This study aims to understand the impact of backpack carriage, a regular activity for many, on back muscles and joint mobility during walking so that clinicians can develop strategies or products to ensure individuals' safety and well-being. Surface electromyography (EMG) and XSENS Awinda motion capture systems were used to analyze the effects of carrying a backpack (12% of body weight) on erector spinae and multifidus muscles, as well as spinal, hip, knee, and ankle joints. Subjects walked at 4 km/h on flat and inclined surfaces.

View Article and Find Full Text PDF

Bruton's tyrosine kinase inhibitor for multiple sclerosis: new hope or false dawn.

J Neurol

January 2025

Institute of Psychological Medicine and Clinical Neuroscience, Cardiff University, University Hospital of Wales, Heath Park, Cardiff, CF14 4XN, UK.

The first of several phase 3 trials examining efficacy in relapsing MS has not been able to demonstrate a significant benefit and has also raised important safety concerns. More results are on their way and it will be important to understand whether the safety signals identified are drug- or class-specific and whether other BTKi also fail to reach their endpoints for relapsing MS. However, as reported in preliminary data for another BTKi, it may be that they will have more of a role in progressive disease as hinted by the unraveling of relevant molecular mechanisms and pathways.

View Article and Find Full Text PDF

Introduction: A hybrid approach with very high-power short-duration (vHPSD) posteriorly and ablation-index guided HPSD (50 W) anteriorly seems to be an optimal balance between efficiency and effectiveness for point-by-point pulmonary vein isolation (PVI). The aim of the current study is to compare vHPSD/HPSD ablation to cryoballoon ablation (CBA) in patients with symptomatic atrial fibrillation (AF).

Methods And Results: In this retrospective single-center study, we identified 110 consecutive patients who underwent their first PVI with either vHPSD/HPSD (n = 54) or CBA (n = 56).

View Article and Find Full Text PDF

Safety of accessing brachial veins for large-bore upper extremity venous thrombectomy using ClotTriever Thrombectomy System.

CVIR Endovasc

January 2025

Department of Radiology, Section of Vascular and Interventional Radiology, University of Washington, 1959 Northeast Pacific Street, Seattle, WA, 98195, USA.

Purpose: To evaluate access site adverse events following ClotTriever-mediated large-bore mechanical thrombectomy via small upper extremity deep veins (< 6-mm).

Materials And Methods: Twenty patients, including 24 upper extremity venous access sites, underwent ClotTriever-mediated large-bore thrombectomy of the upper extremity and thoracic central veins for symptomatic deep vein obstruction unresponsive to anticoagulation. Patients without follow-up venous duplex examinations (n = 3) were excluded.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!