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Abstract

In Japan, data on indirect immunotoxicity tests but not direct immunotoxicity tests are required for new drug applications. Antigenicity studies among indirect immunotoxicity tests are conducted on a case-by-case basis and empirically evaluated by acute systemic anaphylaxis and passive cutaneous anaphylaxis reactions in guinea pigs. The remaining skin sensitization and skin photosensitization studies are regulated by guidelines for dermatological preparations. Respecting direct immunotoxicity tests, a Japan Pharmaceutical Manufacturers Association (JPMA) questionnaire made it clear that some pharmaceutical companies have established the testing capabilities in their laboratories. In this paper, the practice of preclinical immunotoxicity testing in Japan is presented in comparison with those of the United States and the European Union.

Keywords

Immunotoxicity Guinea pig antigenicity Active systemic anaphylaxis Passive cutaneous anaphylaxis Skin sensitization Skin photosensitization

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The Practice of Preclinical Immunotoxicity Testing in Japan

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