Tatsiana Dudzina
Research Subjects
Tatsiana Dudzina has a total of 9 co-authors. Here are the top co-authors by number of shared publications:
- Andreea Cuciureanu
ECETOC AISBL, Bruxelles, Belgium
1 shared publication - Bennard van Ravenzwaay
Environmental Sciences Consulting, Altrip, Germany
1 shared publication - John E. Doe
School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK
1 shared publication - Marcel Leist
Department of in vitro toxicology and biomedicine, Faculty of Sciences, University of Konstanz, Konstanz, Germany
1 shared publication - Mark Timothy David Cronin
Liverpool John Moores University, Liverpool, UK
1 shared publication - Nicholas Ball
Dow Europe GmbH, Bachtobelstrasse, 8810, Horgen, Switzerland
1 shared publication
Latest Publications
- Top Cited PapersOpen Access
- 1 February 2022
- Published by Springer Nature in Archives of Toxicology
- Vol. 96 (3) , 743-766
A framework for chemical safety assessment incorporating new approach methodologies within REACH
The long-term investment in new approach methodologies (NAMs) within the EU and other parts of the world is beginning to result in an emerging consensus of how to use information from in silico, in vitro and targeted in vivo sources to assess the safety of chemicals. However, this methodology is being adopted very slowly for regulatory purposes. Here, we have developed a framework incorporating in silico, in vitro and in vivo methods designed to meet the requirements of REACH in which both hazard and exposure can be assessed using a tiered approach. The outputs from each tier are classification categories, safe doses, and risk assessments, and progress through the tiers depends on the output from previous tiers. We have exemplified the use of the framework with three examples. The outputs were the same or more conservative than parallel assessments based on conventional studies. The framework allows a transparent and phased introduction of NAMs in chemical safety assessment and enables science-based safety decisions which provide the same level of public health protection using fewer animals, taking less time, and using less financial and expert resource. Furthermore, it would also allow new methods to be incorporated as they develop through continuous selective evolution rather than periodic revolution.
- 1 February 2022
- Published by Springer Nature in Archives of Toxicology
- Vol. 96 (3) , 743-766
Top Cited PapersOpen AccessA framework for chemical safety assessment incorporating new approach methodologies within REACH
The long-term investment in new approach methodologies (NAMs) within the EU and other parts of the world is beginning to result in an emerging consensus of how to use information from in silico, in vitro and targeted in vivo sources to assess the safety of chemicals. However, this methodology is being adopted very slowly for regulatory purposes. Here, we have developed a framework incorporating in silico, in vitro and in vivo methods designed to meet the requirements of REACH in which both hazard and exposure can be assessed using a tiered approach. The outputs from each tier are classification categories, safe doses, and risk assessments, and progress through the tiers depends on the output from previous tiers. We have exemplified the use of the framework with three examples. The outputs were the same or more conservative than parallel assessments based on conventional studies. The framework allows a transparent and phased introduction of NAMs in chemical safety assessment and enables science-based safety decisions which provide the same level of public health protection using fewer animals, taking less time, and using less financial and expert resource. Furthermore, it would also allow new methods to be incorporated as they develop through continuous selective evolution rather than periodic revolution.