[监管科学促进创新药开发环境的改善]。

Q4 Medicine

Bulletin of National Institute of Health Sciences Pub Date : 2013-01-01

Toru Kawanishi

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引用次数: 0

摘要

内阁府科学技术政策委员会指出了监管科学在创新药开发中的重要性，从2012年开始，国立卫生研究院制药相关部门开始了监管科学研究，以促进创新药开发环境的改善。选择纳米药物、全工程化蛋白药物、核酸药物、基因治疗药物等作为创新药物，制定主要评价这些药物质量和非临床安全性的考虑点文件。此外，还将提出首次人体试验的条件，特别是从质量和非临床安全性评价的角度。

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[Regulatory science promoting improvement in developing environment of innovative drugs].

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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来源期刊

Bulletin of National Institute of Health Sciences Medicine-Medicine (all)

CiteScore

0.20

自引率

0.00%

发文量