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Article History

Received: 11 November 2025

Accepted: 11 December 2025

First Online: 13 February 2026

Declarations

:

: Helen Tinwell is, and Remi Bars was formerly employed by Bayer SAS. Kim Travis and Remi Bars are consultants with Regulatory Science Associates, who were paid by Bayer to write the manuscript.

: The animal studies were evaluated by the ethical committee of the laboratory in order to guarantee that the animal welfare was considered on the basis of the cutting-edge knowledge of laboratory animal sciences. The care and use of animals was in accordance with the “Décret n° 2013 − 118 du 1er février 2013 relatif à la protection des animaux utilisés à des fins scientifiques”: implementation into the French law of “The Directive 2010/63/EU of the European Parliament and the Council of 22 September 2010 on the protection of animals used for scientific purposes, by the Official Journal of the European Union, L276/33–79, 2010”.All studies involving human samples were performed in line with the principles of the Declaration of Helsinki, including obtaining informed consent. These studies are: two using human hepatocytes, one using pooled human liver microsomes and one using human lymphocytes.