2025 SETAC Europe Presentations
Smithers Ecotoxicology and Environmental Fate & Metabolism scientists will present during the SETAC Europe Annual Meeting in Vienna. View the list of posters
2025 SETAC Europe Poster: A Consistent Framework for Literature Reviews Improves Confidence in Environmental Risk Assessment of Pharmaceuticals
The 2024 EMA Guideline on ERA of Human Medicinal Products encourages the use of literature studies as alternatives to requisite empirical studies and to minimize animal testing for active pharmaceutical ingredients (APIs). However, limited guidance is provided on how to conduct the literature data search. Furthermore, the Guideline also lacks clarity on how to use the data resulting from the literature reviews, potentially leading to inconsistent use of the literature data. Hence, a framework has been proposed (see accompanying poster) to screen relevant studies and to critically assess their relevance and reliability in a robust and consistent manner.
We provide a case study of how literature data on fish ecotoxicity studies can be used in the context of EMA-required ERA and what needs to be considered to clarify the use of literature studies/data in supporting ERAs and embracing the 3Rs principles as intended in the Guideline.
Dr. Sharon Swales will co-present this research during the SETAC Europe 35th Annual Meeting, May 11-15, in Vienna, Austria. Meet with the Smithers team at stand 33 during the conference.