Drug Delivery System
Online ISSN : 1881-2732
Print ISSN : 0913-5006
ISSN-L : 0913-5006
[Feature articles] “Precise design and structural control of polymer materials for DDS” Editor:Atsushi Maruyama
Characterization of nanomedicine in terms of regulatory science perspective
Kazuo Sakurai
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2019 Volume 34 Issue 3 Pages 201-207

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Abstract
Liposomes and polymeric micelles containing a biologically active compound or polymers bearing pro-drug at their side chains can be categorized into “nanomedicines”. The size of the nanomedicines is in the range of 1-100 nm and the size is essential to induce biological efficacy such as biodistribution. Characterizing their accurate structures and properties, which is required by FDA, is important in terms of CMC. We presume that light or X-ray static scattering combined with a fractionation tool by use of gel or filed flow meet such demand.
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© 2019 The Japan Society of Drug Delivery System
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