Annual Meeting of the Japanese Society of Toxicology
The 47th Annual Meeting of the Japanese Society of Toxicology
Session ID : S13-1
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Symposium 13
An overview of the Three Rs in assessing the safety of pharmaceuticals
*Hajime KOJIMA
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CONFERENCE PROCEEDINGS FREE ACCESS

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Abstract

The Three Rs―replacement, reduction, and refinement―are guiding principles for the ethical use of animals. In recent years, a number of test methods incorporating these principles have been adopted by the OECD, the ISO, and other international organizations. The Three Rs have been an integral part of a number of ICH guidelines published since the 1990’s, including ICH S2 on genotoxicity testing, ICH S5 on reproductive toxicology, and ICH S10 on the photosafety evaluation of chemicals. Moreover, since 2009, these principles have been incorporated into ICH M3 R2 Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals.

Test developers continue to research new in vitro, in chemico, and in silica test methods, which suggests that the development of alternatives to animal testing that incorporate the three principles of replacement, reduction, and refinement will continue indefinitely into the future.

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© 2020 The Japanese Society of Toxicology
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