Regulatory considerations on the evaluation of companion diagnostics (CDx) in Japan

Abstract

IntroductionCDx are getting very important in the drug development. Recent trends in developments and regulations of CDx in Japan will be introduced. A regulatory documents on the CDx has been released by the Ministry of... [ view full abstract ]

Authors

  1. Takayoshi Suzuki (National Institute of Health Sciences)
  2. Yoshinori Tsukumo (National Institute of Health Sciences)
  3. Arihiro Kohara (National Institutes of Biomedical Innovation, Health and Nutrition)
  4. Mikihiko Naito (National Institute of Health Sciences)

Topic Area

Biomarkers and diagnostics, liquid biopsy, imaging, biochip/microarray technologies, advan

Session

PS3 » Poster Session (13:30 - Wednesday, 27th June, Main hall)

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