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 …

Chitosan-based in situ gels for ocular delivery of therapeutics: a state-of-the-art review

T Irimia, CE Dinu-Pîrvu, MV Ghica, D Lupuleasa… - Marine drugs, 2018 - mdpi.com
Ocular in situ gels are a promising alternative to overcome drawbacks of conventional eye
drops because they associate the advantages of solutions such as accuracy and …

Machine learning of toxicological big data enables read-across structure activity relationships (RASAR) outperforming animal test reproducibility

T Luechtefeld, D Marsh, C Rowlands… - Toxicological …, 2018 - academic.oup.com
Earlier we created a chemical hazard database via natural language processing of dossiers
submitted to the European Chemical Agency with approximately 10 000 chemicals. We …

Replacement of animal testing by integrated approaches to testing and assessment (IATA): a call for in vivitrosi

F Caloni, I De Angelis, T Hartung - Archives of Toxicology, 2022 - Springer
Alternative methods to animal use in toxicology are evolving with new advanced tools and
multilevel approaches, to answer from one side to 3Rs requirements, and on the other side …

[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 …

[HTML][HTML] Analysis of Draize eye irritation testing and its prediction by mining publicly available 2008–2014 REACH data

T Luechtefeld, A Maertens, DP Russo, C Rovida, H Zhu… - Altex, 2016 - ncbi.nlm.nih.gov
Public data from ECHA online dossiers on 9,801 substances encompassing 326,749
experimental key studies and additional information on classification and labeling were …

Cosmetics Europe compilation of historical serious eye damage/eye irritation in vivo data analysed by drivers of classification to support the selection of chemicals for …

J Barroso, U Pfannenbecker, E Adriaens, N Alépée… - Archives of …, 2017 - Springer
A thorough understanding of which of the effects assessed in the in vivo Draize eye test are
responsible for driving UN GHS/EU CLP classification is critical for an adequate selection of …

Big-data and machine learning to revamp computational toxicology and its use in risk assessment

T Luechtefeld, C Rowlands, T Hartung - Toxicology research, 2018 - academic.oup.com
The creation of large toxicological databases and advances in machine-learning techniques
have empowered computational approaches in toxicology. Work with these large databases …

In vitro and in vivo evaluation of in situ gelling systems for sustained topical ophthalmic delivery: state of the art and beyond

PL Destruel, N Zeng, M Maury, N Mignet, V Boudy - Drug discovery today, 2017 - Elsevier
Highlights•A guideline for the development of ophthalmic in situ gelling systems is
proposed.•Gelation, gelation kinetics and rheological characterization methods are …

Human-relevant approaches to assess eye corrosion/irritation potential of agrochemical formulations

AJ Clippinger, HA Raabe, DG Allen… - … and ocular toxicology, 2021 - Taylor & Francis
There are multiple in vitro and ex vivo eye irritation and corrosion test methods that are
available as internationally harmonized test guidelines for regulatory use. Despite their …