Enhancing global and local decision making for chemical safety assessments through increasing the availability of data

An Evaluation of the Occupational Health Hazards of Peptide Couplers

(2022) Jessica C. Graham et al.   CHEMICAL RESEARCH IN TOXICOLOGY

Evaluation of Variability Across Rat Acute Oral Systemic Toxicity Studies

(2022) Agnes L Karmaus et al.   TOXICOLOGICAL SCIENCES

The Evolution of Regulatory Toxicology: Where is the Gardener?

(2022) Robert Landsiedel et al.   ATLA-ALTERNATIVES TO LABORATORY ANIMALS

The role of ‘big data’ and ‘in silico’ New Approach Methodologies (NAMs) in ending animal use – A commentary on progress

(2022) Rebecca N. Ram et al.   Computational Toxicology

How to resolve inconclusive predictions from defined approaches for skin sensitisation in OECD Guideline No. 497

(2022) Donna S. Macmillan et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Improvements to in silico skin sensitisation predictions through privacy-preserving data sharing

(2022) Donna S. Macmillan et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Employing an adverse outcome pathway framework for weight-of-evidence assessment with application to the ICH S1B guidance addendum

(2021) Susanne A. Stalford et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Assessing the impact of expert knowledge on ICH M7 (Q)SAR predictions. Is expert review still needed?

(2021) P. Suresh Jayasekara et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

An evaluation framework for new approach methodologies (NAMs) for human health safety assessment

(2020) Stanley T. Parish et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Pathways for N-nitroso compound formation: secondary amines and beyond

(2020) Rocio López-Rodríguez et al.   ORGANIC PROCESS RESEARCH & DEVELOPMENT

Management of pharmaceutical ICH M7 (Q)SAR predictions – The impact of model updates

(2020) Catrin Hasselgren et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

FL-QSAR: a federated learning-based QSAR prototype for collaborative drug discovery

(2020) Shaoqi Chen et al.   BIOINFORMATICS

Are all bacterial strains required by OECD mutagenicity test guideline TG471 needed?

(2019) Richard V. Williams et al.   MUTATION RESEARCH-GENETIC TOXICOLOGY AND ENVIRONMENTAL MUTAGENESIS

Adverse outcome pathway networks I: Development and applications

(2018) Dries Knapen et al.   ENVIRONMENTAL TOXICOLOGY AND CHEMISTRY

Potential impurities in drug substances: Compound-specific toxicology limits for 20 synthetic reagents and by-products, and a class-specific toxicology limit for alkyl bromides

(2018) J.P. Bercu et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Distinguishing between expert and statistical systems for application under ICH M7

(2017) Chris Barber et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Resolution of contradiction between in silico predictions and Ames test results for four pharmaceutically relevant impurities

(2017) William C. Gunther et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Evaluation of a statistics-based Ames mutagenicity QSAR model and interpretation of the results obtained

(2016) Chris Barber et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

The FAIR Guiding Principles for scientific data management and stewardship

(2016) Mark D. Wilkinson et al.   Scientific Data

Investigating a Relationship between the Mutagenicity of Arylboronic Acids and 11B NMR Chemical Shifts

(2015) Maria L. Pellizzaro et al.   CHEMICAL RESEARCH IN TOXICOLOGY

Do Carboxylic/Sulfonic Acid Halides Really Present a Mutagenic and Carcinogenic Risk as Impurities in Final Drug Products?

(2015) Alexander Amberg et al.   ORGANIC PROCESS RESEARCH & DEVELOPMENT

A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing

(2014) David Basketter   ALTEX-Alternatives to Animal Experimentation

Self organising hypothesis networks: a new approach for representing and structuring SAR knowledge

(2014) Thierry Hanser et al.   Journal of Cheminformatics

Reducing safety-related drug attrition: the use of in vitro pharmacological profiling

(2012) Joanne Bowes et al.   NATURE REVIEWS DRUG DISCOVERY

Adverse outcome pathways: A conceptual framework to support ecotoxicology research and risk assessment

(2010) Gerald T. Ankley et al.   ENVIRONMENTAL TOXICOLOGY AND CHEMISTRY

A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development

(2007) Sally Robinson et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY