[Regulatory science researches of nanomedicines].

Q4 Medicine Bulletin of National Institute of Health Sciences Pub Date : 2014-01-01
Kumiko Sakai-Kato, Yukihiro Goda
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Abstract

Recently, the development of nanomedicines is progressing. These are designed to ensure high stability and to optimize the pharmacokinetics in vivo. The polymeric micelles and lipid nanoparticles are typical such examples. Because the unique size-specific interaction with biological systems or biodistribution may have significant impacts on the efficacy and safety of nanomedicines, regulatory science researches of nanomedicines are required. In this review, the authors introduce our initiatives of the regulatory science researches of nanomedicines.

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[纳米药物调控科学研究]。
近年来,纳米药物的研究取得了很大进展。这些设计是为了确保高稳定性和优化体内药代动力学。聚合物胶束和脂质纳米颗粒就是典型的例子。由于纳米药物与生物系统或生物分布的独特的尺寸特异性相互作用可能对纳米药物的有效性和安全性产生重大影响,因此需要对纳米药物进行监管科学研究。本文综述了我国纳米药物调控科学研究的进展。
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[Activity report on a programe of the Ministry of Health, Labour and Welfare (MHLW) "Initiative to facilitate development of innovative drugs, medical devices, and cellular and tissue-based products" in National Institute of Health Sciences]. [Regulatory science researches of nanomedicines]. [Translational/regulatory science researches of NIHS for regenerative medicine and cellular therapy products]. [Collaborative study on regulatory science for facilitating clinical development of gene therapy products for genetic diseases]. [Study toward practical use of oligonucleotide therapeutics].
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