Art
J-GLOBAL ID：201902252402474525   Reference number：19A1366282

モノクローナル抗体医薬品の翻訳後修飾[その1]

Author (1)：
NIIMI SHINGO

About NIIMI SHINGO

(日本化薬 医薬研)

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Material：
医薬品医療機器レギュラトリーサイエンス  (Pharmaceutical and Medical Device Regulatory Science)

About 医薬品医療機器レギュラトリーサイエンス


Volume： 50  Issue： 6  Page： 307-313  Publication year： Jun. 10, 2019 
JST Material Number： F0456B  ISSN： 1884-6076  CODEN： IIKRA9  Document type： Article
Article type： 解説  Country of issue： Japan (JPN)  Language： JAPANESE (JA)
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monoclonal antibody

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,...
Semi thesaurus term：
Thesaurus term/Semi thesaurus term
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All keywords is available on JDreamIII(charged).
On J-GLOBAL, this item will be available after more than half a year after the record posted. In addtion, medical articles require to login to MyJ-GLOBAL.
*C末端修飾

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JST classification (1)：
JST classification
Category name(code) classified by JST.
Research and development 
(GU01040N)

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Substance index (2)：
Substance index
Chemical Substance indexed to the Article.
Pyroglutamic acid

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, 
Proline

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Reference (47)：
  • Liu, H.; Gaza-Bulseco, G.; Faldu, D.; Chumsae, C.; Sun, J. Heterogeneity of Monoclonal Antibodies. J. Pharm. Sci. 2008,97(7),p.2426-2447.
  • ICH Q8 製剤開発に関するガイドラインの改定.https://www.pmda.go.jp/files/000156605.pdf(accessed 2018-11-15)
  • Finkler, C.; Krummen, L. Introduction to the Application of QbD Principles for the Development of Monoclonal Antibodies. Biologicals. 2016,44(5), p.282-290. doi:10.1016/j.biologicals.2016.07.004.
  • Bhatia, H.; Read, E.; Agarabi, C.; Brorson, K.; Lute, S.; Yoon, S. A Design Space Exploration for Control of Critical Quality Attributes of mAb. Int. J. Pharm. 2016,512(1), p.242-252. doi:10.1016/j.ijpharm.2016.08.046.
  • Alt, N.; Zhang, T.Y.; Motchnik, P.; Taticek, R; Quarmby, V.; Schlothauer, T.; Beck, H.; Emrich, T.; Harris, R.J. Determination of Critical Quality Attributes for Monoclonal Antibodies using Quality by Design Principles. Biologicals. 2016,44(5), p.291-305. doi:10.1016/j. biologicals.2016.06.005.
ｍore...
Terms in the title (3)：
Terms in the title
Keywords automatically extracted from the title.
モノクローナル抗体

About モノクローナル抗体

, 
医薬品

About 医薬品

, 
翻訳後修飾

About 翻訳後修飾


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