A framework for establishing scientific confidence in new approach methodologies

AJ Van Der Zalm, J Barroso, P Browne, W Casey… - Archives of …, 2022‏ - Springer
Robust and efficient processes are needed to establish scientific confidence in new
approach methodologies (NAMs) if they are to be considered for regulatory applications …

[HTML][HTML] Application of AOPs to assist regulatory assessment of chemical risks–Case studies, needs and recommendations

L Bajard, O Adamovsky, K Audouze, K Baken… - Environmental …, 2023‏ - Elsevier
While human regulatory risk assessment (RA) still largely relies on animal studies, new
approach methodologies (NAMs) based on in vitro, in silico or non-mammalian alternative …

Animal to human translation: a systematic sco** review of reported concordance rates

CHC Leenaars, C Kouwenaar, FR Stafleu… - Journal of translational …, 2019‏ - Springer
Background Drug development is currently hampered by high attrition rates; many
developed treatments fail during clinical testing. Part of the attrition may be due to low …

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

ST Parish, M Aschner, W Casey, M Corvaro… - Regulatory Toxicology …, 2020‏ - Elsevier
The need to develop new tools and increase capacity to test pharmaceuticals and other
chemicals for potential adverse impacts on human health and the environment is an active …

Probabilistic risk assessment–the keystone for the future of toxicology

A Maertens, E Golden, TH Luechtefeld, S Hoffmann… - Altex, 2022‏ - pmc.ncbi.nlm.nih.gov
Safety sciences must cope with uncertainty of models and results as well as information
gaps. Acknowledging this uncertainty necessitates embracing probabilities and accepting …

Non-animal methods to predict skin sensitization (II): an assessment of defined approaches

NC Kleinstreuer, S Hoffmann, N Alépée… - Critical reviews in …, 2018‏ - Taylor & Francis
Skin sensitization is a toxicity endpoint of widespread concern, for which the mechanistic
understanding and concurrent necessity for non-animal testing approaches have evolved to …

Development of a next generation risk assessment framework for the evaluation of skin sensitisation of cosmetic ingredients

N Gilmour, PS Kern, N Alépée, F Boislève… - Regulatory Toxicology …, 2020‏ - Elsevier
All cosmetic products placed onto the market must undergo a risk assessment for human
health to ensure they are safe for consumers, including an assessment of skin sensitisation …

[HTML][HTML] An analysis of the limitations and uncertainties of in vivo developmental neurotoxicity testing and assessment to identify the potential for alternative …

M Paparella, SH Bennekou, A Bal-Price - Reproductive Toxicology, 2020‏ - Elsevier
Limitations of regulatory in vivo developmental neurotoxicity (DNT) testing and assessment
are well known, such as the 3Rs conflict, low throughput, high costs, high specific expertise …

Use of human predictive patch test (HPPT) data for the classification of skin sensitization hazard and potency

M Herzler, J Abedini, DG Allen, D Germolec… - Archives of …, 2024‏ - Springer
Since the 1940s, patch tests in healthy volunteers (Human Predictive Patch Tests, HPPTs)
have been used to identify chemicals that cause skin sensitization in humans. Recently, we …

Pred-skin: a web portal for accurate prediction of human skin sensitizers

JVB Borba, RC Braga, VM Alves… - Chemical Research …, 2020‏ - ACS Publications
Safety assessment is an essential component of the regulatory acceptance of industrial
chemicals. Previously, we have developed a model to predict the skin sensitization potential …