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Updated: May 4, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
[Regulatory science promoting improvement in developing environment of innovative drugs]
1National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501, Japan. kawanish@nihs.go.jp
Abstract:
Importance of regulatory science in development of innovative drugs is pointed out by the Council for Science and Technology Policy in the Cabinet Office, and the pharmaceuticals-related divisions in the NIHS have begun the regulatory science research for promoting improvement in developing environment of innovative drugs since 2012. Nano-medicines, fully engineered protein drugs, nucleic acid drugs, and gene therapy drugs have been selected as innovative drugs, and the point-to-consider documents for evaluating mainly quality and non-clinical safety of these drugs will be developed. In addition, the conditions for the first-in-human trial will be also proposed, especially from the standpoints of quality and non-clinical safety evaluation.
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