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Lookup NU author(s): Professor Anne Dickinson
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).
© 2024 The Japanese Society of Toxicologic Pathology.The United States Senate passed the “FDA Modernization Act 2.0.” on September 29, 2022. Although the effectiveness of this Bill, which aims to eliminate the mandatory use of laboratory animals in new drug development, is limited, it represents a significant trend that will change the shape of drug applications in the United States and other countries. However, pharmaceutical companies have not taken major steps towards the complete elimination of animal testing from the standpoint of product safety, where they prioritize patient safety. Nonetheless, society is becoming increasingly opposed to animal testing, and efforts will be made to use fewer animals and conduct fewer animal tests as a natural and reasonable response. These changes eventually alter the shape of new drug applications. Based on the assumption that fewer animal tests will be conducted or fewer animals will be used in testing, this study explored bioinformatics and new technologies as alternatives to compensate for reduced information and provide a picture of how future new drug applications may look. The authors also discuss the directions that pharmaceutical companies and nonclinical contract research organizations should adopt to promote the replacement, reduction, and refinement of animals used in research, teaching, testing, and exhibitions.
Author(s): Anzai T, Myatt GJ, Hall F, Finney B, Nakagawa K, Iwata H, Anzai R, Dickinson A, Freer M, Nakae D, Onodera H, Matsuyama T
Publication type: Review
Publication status: Published
Journal: Journal of Toxicologic Pathology
Year: 2024
Volume: 37
Issue: 2
Pages: 45-53
Print publication date: 02/04/2024
Online publication date: 22/11/2023
Acceptance date: 09/11/2023
ISSN (print): 0914-9198
ISSN (electronic): 1881-915X
Publisher: Japanese Society of Toxicologic Pathology
URL: https://doi.org/10.1293/tox.2023-0106
DOI: 10.1293/tox.2023-0106
