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[Current Status and Regulatory Issues of Companion Diagnostics in Japan].

Gan to kagaku ryoho. Cancer & chemotherapy - 1 Apr 2024

Tsukumo Yoshinori, Inoue Takao

Abstract excerpt

Companion diagnostics(CDx)are in vitro diagnostic products that are used to predict the efficacy and adverse effects of therapeutic drugs prior to administration, and are co-developed and co-approved with the therapeutic drugs in principle. In Japan, 40 CDx products have been approved by January 2024, and 39 products are used to determine if therapeutic drugs are applicable for cancer treatment. In the CDx...

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PMID: 38644299

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