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J-GLOBAL ID：201602220365386177   Reference number：16A0048137

ワクチン開発をめぐるレギュレーションの最新動向について

Author (1)：
HAMAGUCHI ISAO

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(感染症研)

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Material：
薬剤学  (Journal of Pharmaceutical Science and Technology, Japan)

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Volume： 76  Issue： 1  Page： 51-54  Publication year： Jan. 01, 2016 
JST Material Number： G0234A  ISSN： 0372-7629  CODEN： YAKUA  Document type： Article
Article type： 解説  Country of issue： Japan (JPN)  Language： JAPANESE (JA)
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*regulation

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,...
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*Drug regulation

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JST classification (2)：
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Category name(code) classified by JST.
Pharmaceutical affairs,pharmaceutical practice 
(GU01020R)

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,  Basic research of immunotherapeutic agents and blood preparations 
(GW22010D)

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Reference (5)：
  • 1) 厚生労働省科学研究費補助金「ワクチン開発における臨床評価ガイドラン等の作成に関する研究」(山西 弘一代表) 平成19年~21年度総合研究報告書.
  • 2) 厚生労働省科学研究費補助金「次世代型ワクチンの実用化に向けた検討及び品質管理に関する基準の在り方に関する研究」(石井健代表) 平成25年度総括分担研究報告書.
  • 3) WHO, Guidelines for Independent Lot Release of Vaccines by Regulatory Authorities, 2010.
  • 4) T. Mizukami, et al., Application of complementary DNA microarray technology to influenza A/Vietnam/1194/2004 (H5N1) vaccine safety evaluation, Vaccine, 26, 2270-2283 (2008).
  • 5) T. Mizukami, et al., System vaccinology for the evaluation of influenza vaccine safety by multiplex gene detection of novel biomarkers in a preclinical study and batch release test, PLoS One, 9 (7), e101835 (2014).
Terms in the title (3)：
Terms in the title
Keywords automatically extracted from the title.
ワクチン

About ワクチン

, 
開発

About 開発

, 
最新動向

About 最新動向


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