Barry Hardy
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View article: Transcriptomic changes and mitochondrial toxicity in response to acute and repeat dose treatment with brequinar in human liver and kidney in vitro models
Transcriptomic changes and mitochondrial toxicity in response to acute and repeat dose treatment with brequinar in human liver and kidney in vitro models Open
The potent dihydroorotate dehydrogenase (DHODH) inhibitor brequinar has been investigated as an anticancer, immunosuppressive, and antiviral pharmaceutical agent. However, its toxicity is still poorly understood. We investigated the cellul…
View article: The long way from raw data to NAM-based information: Overview on data layers and processing steps
The long way from raw data to NAM-based information: Overview on data layers and processing steps Open
Toxicological test methods generate raw data and provide instructions on how to use these to determine a final outcome such as a classification of test compounds as hits or non-hits. The data processing pipeline provided in the test method…
View article: Developmental neurotoxicity (DNT): A call for implementation of new approach methodologies for regulatory purposes: Summary of the 5th International Conference on DNT Testing
Developmental neurotoxicity (DNT): A call for implementation of new approach methodologies for regulatory purposes: Summary of the 5th International Conference on DNT Testing Open
The 5th International Conference on Developmental Neurotoxicity (DNT) Testing (DNT5) took place in April 2024 in Konstanz, Germany, organized by CAAT-Europe, the University of Konstanz, and scientists from the US EPA, SCAHT, and CAAT at Jo…
View article: Development of a comprehensive open access “molecules with androgenic activity resource (MAAR)” to facilitate risk assessment of chemicals
Development of a comprehensive open access “molecules with androgenic activity resource (MAAR)” to facilitate risk assessment of chemicals Open
The increasing prevalence of endocrine-disrupting chemicals (EDCs) and their potential adverse effects on human health underscore the necessity for robust tools to assess and manage associated risks. The androgen receptor (AR) is a critica…
View article: Increasing Accessibility of Bayesian Network-Based Defined Approaches for Skin Sensitisation Potency Assessment
Increasing Accessibility of Bayesian Network-Based Defined Approaches for Skin Sensitisation Potency Assessment Open
Skin sensitisation is a critical adverse effect assessed to ensure the safety of compounds and materials exposed to the skin. Alongside the development of new approach methodologies (NAMs), defined approaches (DAs) have been established to…
View article: Skin Sensitisation Case Study: Comparison of Defined Approaches including OECD 497 Guidance
Skin Sensitisation Case Study: Comparison of Defined Approaches including OECD 497 Guidance Open
Characterising known and new chemical compounds for skin sensitisation provides a basis for the development of safer products where ingredients are exposed to skin. By including new approaches, such as tiered testing strategies and integra…
View article: An in vitro strategy using multiple human induced pluripotent stem cell-derived models to assess the toxicity of chemicals: A case study on paraquat
An in vitro strategy using multiple human induced pluripotent stem cell-derived models to assess the toxicity of chemicals: A case study on paraquat Open
Most OECD guidelines for chemical risk assessment include tests performed on animals, raising financial, ethical and scientific concerns. Thus, the development of human-based models for toxicity testing is highly encouraged. Here, we propo…
View article: Skin sensitization in silico protocol
Skin sensitization in silico protocol Open
The assessment of skin sensitization has evolved over the past few years to include in vitro assessments of key events along the adverse outcome pathway and opportunistically capitalize on the strengths of in silico methods to support a we…
View article: https://www.altex.org/index.php/altex/article/view/1339
https://www.altex.org/index.php/altex/article/view/1339 Open
Only few cell-based test methods are described by Organisation for Economic Co-operation and Development (OECD) test guidelines or other regulatory references (e.g., the European Pharmacopoeia). The majority of toxicity tests still falls i…
View article: Integrated analysis of in vitro data and the adverse outcome pathway framework for prioritization and regulatory applications: An exploratory case study using publicly available data on piperonyl butoxide and liver models
Integrated analysis of in vitro data and the adverse outcome pathway framework for prioritization and regulatory applications: An exploratory case study using publicly available data on piperonyl butoxide and liver models Open
The integration of existing knowledge to support the risk assessment of chemicals is an ongoing challenge for scientists, risk assessors and risk managers. In addition, European Union regulations limiting the use of new animal testing in c…
View article: Emerging technologies for food and drug safety
Emerging technologies for food and drug safety Open
Emerging technologies are playing a major role in the generation of new approaches to assess the safety of both foods and drugs. However, the integration of emerging technologies in the regulatory decision-making process requires rigorous …
View article: Supporting evidence-based analysis for modified risk tobacco products through a toxicology data-sharing infrastructure
Supporting evidence-based analysis for modified risk tobacco products through a toxicology data-sharing infrastructure Open
The US FDA defines modified risk tobacco products (MRTPs) as products that aim to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. Establishing a product’s potential as an MRTP requ…
View article: Supporting evidence-based analysis for modified risk tobacco products through a toxicology data-sharing infrastructure
Supporting evidence-based analysis for modified risk tobacco products through a toxicology data-sharing infrastructure Open
The US FDA defines modified risk tobacco products (MRTPs) as products that aim to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. Establishing a product’s potential as an MRTP requ…
View article: Toward the Replacement of Animal Experiments through the Bioinformatics-driven Analysis of ‘Omics’ Data from Human Cell Cultures
Toward the Replacement of Animal Experiments through the Bioinformatics-driven Analysis of ‘Omics’ Data from Human Cell Cultures Open
This paper outlines the work for which Roland Grafström and Pekka Kohonen were awarded the 2014 Lush Science Prize. The research activities of the Grafström laboratory have, for many years, covered cancer biology studies, as well as the de…
View article: The eNanoMapper database for nanomaterial safety information
The eNanoMapper database for nanomaterial safety information Open
Background: The NanoSafety Cluster, a cluster of projects funded by the European Commision, identified the need for a computational infrastructure for toxicological data management of engineered nanomaterials (ENMs). Ontologies, open stand…
View article: Deliverable Report D2.3 Ontology initial release
Deliverable Report D2.3 Ontology initial release Open
The eNanoMapper project aims to build an ontology and database to collate and describe data relevant for “safe by design” engineered nanomaterial development. Work Package 2 of this effort is developing and disseminating a comprehensive on…