ＭＺＴ（株）ゼブラフィッシュ創薬研究所

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ICH and 3Rs with zebrafish-based alternative methos

New Horizons in Alternatives with Zebrafish to Animal Experiments
シンポジウム『ゼブラフィッシュによる代替法の新しい展開』

The purpose of the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use(ICH) is to make recommendations to achieve greater harmonization regarding interpretation and application of technical guidelines and requirements for product registration in an effort to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines. The ICH process has contributed to mutual understanding of the regulatory requirements and has decreased the number of unnecessary animal experiments and to the 3Rs (Replacement, Reduction and Refinement). In this symposium, we demonstrate that the emerging zebrafish-based “alternative” methods enabling replacement, reduction, or refinement (the 3Rs). Over the ten years zebrafish has become a popular model in the study of toxicology and pharmacology. The high degree of genetic homology with mammals and human, ease of handling and reproduction, as well as great prospects for the application of the genome editing and proteomic technologies,
has fostered the use of zebrafish to spread rapidly in scientific research and regulatory business. Thus these emerging zebrafish-based “alternative” methods reduces the number of animals required to assess toxicity in multiple organs. It refined the drug toxicity evaluation through novel in vivo quantitative physiological parameters. Subsequently, it might allow the replacement of conventional species, such as mammals. Recently, the application of the 3Rs regulation and the characteristics of the embryo have reduced the use of adult zebrafish use of adult zebrafish use in many studies. In the past decade, greate efforts have been madeto incorporate the principle of reduction, refinement and replacement (3Rs) into the acute fish toxicity test (AFT). One of the efforts is the development of the Fish Embryo Acute Toxicity Test (FET) as an alternative to to AFT in order to replace the animal testing in adult fish. Because formally and practically, according to the European Directive 2010/63/EU, zebrafish at the embryonic stages are not be regarded as protected animals.
We will demonstrate some our examples for the 3Rs regulation with embryonic zebrafishes in this symposium.

ＭＺＴ（株）ゼブラフィッシュ創薬研究所

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ICH and 3Rs with zebrafish-based alternative methos

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