Advancing systemic toxicity risk assessment: Evaluation of a NAM-based toolbox approach.

For many years, a method that allowed systemic toxicity safety assessments to be conducted without generating new animal test data, seemed out of reach. However, several different research groups and regulatory authorities are beginning to use a variety of in silico, in chemico, and in vitro techniques to inform safety decisions. To manage this transition to animal-free safety assessments responsibly, it is important to ensure that the level of protection offered by a safety assessment based on new approach methodologies (NAMs), is at least as high as that provided by a safety assessment based on traditional animal studies.

Update of the Cancer Potency Database (CPDB) to enable derivations of Thresholds of Toxicological Concern (TTC) for cancer potency.

The purpose of this study was to update the existing Cancer Potency Database (CPDB) in order to support the development of a dataset of compounds, with associated points of departure (PoDs), to enable a review and update of currently applied values for the Threshold of Toxicological Concern (TTC) for cancer endpoints. This update of the current CPDB, last reviewed in 2012, includes the addition of new data (44 compounds and 158 studies leading to additional 359 dose-response curves). Strict inclusion criteria were established and applied to select compounds and studies with relevant cancer potency data.

2D Strain Analysis in Myocarditis-Can We Be Any Closer to Diagnose the Acute Phase of the Disease?

Background: The aim of present study was to assess left ventricular myocardial deformation detected by 2D STE in patients with suspected acute myocarditis (AM) early on admission in whom later cardiac magnetic resonance (CMR) evaluation was performed.

Methods: A total of 47 patients with suspected AM based on clinical practice were prospectively enrolled. Coronary angiography was performed on all patients to rule out significant coronary artery disease.

Acute coronary syndrome versus acute myocarditis in young adults-value of speckle tracking echocardiography.

Purpose: Comparing myocarditis with an acute coronary syndrome (ACS)-like presentation and acute myocardial infarction (AMI) poses an important clinical challenge. The purpose of the study was to investigate the diagnostic value of the clinical, laboratory and especially echocardiographic characteristics including speckle tracking echocardiography (STE) of patients with ACS-like myocarditis and AMI.

Methods: We conducted a retrospective analysis comparing 69 symptomatic patients (≤ 45 years old), hospitalized at the Department of Interventional Cardiology (Medical University of Lodz, Poland) between April 2014 and June 2021 with an initial diagnosis of ST-segment elevation myocardial infarction.

Next generation risk assessment for skin allergy: Decision making using new approach methodologies.

Our aim is to develop and apply next generation approaches to skin allergy risk assessment (SARA) that do not require new animal test data and better quantify uncertainties. Significant progress has been made in the development of New Approach Methodologies (NAMs), non-animal test methods, for assessment of skin sensitisation and there is now focus on their application to derive potency information for use in Next Generation Risk Assessment (NGRA). The SARA model utilises a Bayesian statistical approach to infer a human-relevant metric of sensitiser potency and a measure of risk associated with a given consumer exposure based upon any combination of human repeat insult patch test, local lymph node, direct peptide reactivity assay, KeratinoSens™, h-CLAT or U-SENS™ data.