薬事申請における安全性試験と動物福祉

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  • Non-clinical safety study and animal welfare in the application for drugs, quasi-drugs and cosmetics
  • ヤクジ シンセイ ニ オケル アンゼンセイ シケン ト ドウブツ フクシ

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In the Pharmaceuticals Affairs Law, development, manufacturing and marketing of drugs, quasi-drugs, cosmetics and medical devices are regulated from the point of view of their quality, efficacy and safety. Non-clinical safety data are required not only to consider relationship between test substances and adverse events occurred in clinical trials at review of the application but also to evaluate safety and ethical appropriateness of protocols of clinical trials during development of them. Alternative tests to animal testing are quite important in the regulation of drugs, quasi-drugs and cosmetics from two viewpoints: one is the animal welfare, and the other is the sufficient evaluation of safety of products. From the administrative point of view, objectives and usages of results of alternative tests for drugs, quasi-drugs and cosmetics should be considered on development, evaluation and validation of alternative tests.

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