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J-GLOBAL ID：201702210568916597   Reference number：17A1371015

Influence of Japanese Regulatory Action on Denosumab-Related Hypocalcemia Using Japanese Adverse Drug Event Report Database

日本医薬品副作用データベースを用いるデノスマブ関連低カルシウム血症に対する日本の規制措置の影響

Author (8)： Takeyama Mayu (Graduate School of Pharmaceutical Sciences, Tohoku University) ,  Takeyama Mayu (Division of Medicinal Safety Science, National Institute of Health Sciences) ,  Sai Kimie (Division of Medicinal Safety Science, National Institute of Health Sciences) ,  Imatoh Takuya (Division of Medicinal Safety Science, National Institute of Health Sciences) ,  Segawa Katsunori (Division of Medicinal Safety Science, National Institute of Health Sciences) ,  Hirasawa Noriyasu (Graduate School of Pharmaceutical Sciences, Tohoku University) ,  Saito Yoshiro (Graduate School of Pharmaceutical Sciences, Tohoku University) ,  Saito Yoshiro (Division of Medicinal Safety Science, National Institute of Health Sciences)
Material： Biological and Pharmaceutical Bulletin  (Biological & Pharmaceutical Bulletin)
Volume： 40  Issue： 9  Page： 1447-1453(J-STAGE)  Publication year： 2017 
JST Material Number： S0989A  ISSN： 0918-6158  CODEN： BPBLEO  Document type： Article
Article type： 原著論文  Country of issue： Japan (JPN)  Language： ENGLISH (EN)

Thesaurus term： human ,...
Semi thesaurus term： *Denosumab ,...

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Author keywords (12)： denosumab ,  regulatory action ,  Japanese Adverse Drug Event Report database ,  hypocalcemia ,  osteonecrosis of the jaw ,  zoledronic acid ,  denosumab ,  regulatory action ,  Japanese Adverse Drug Event Report database ,  hypocalcemia ,  osteonecrosis of the jaw ,  zoledronic acid

JST classification (2)： Pharmacy in general  (GU01010G) ,  Metabolic diseases,nutritional diseases in general.  (GD05010J)

Reference (22)：

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• 3) van Puijenbroek E, Diemont W, van Grootheest K. Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions. Drug Saf., 26, 293-301 (2003).
• 4) Sakaeda T, Tamon A, Kadoyama K, Okuno Y. Data mining of the public version of the FDA Adverse Event Reporting System. Int. J. Med. Sci., 10, 796-803 (2013).
• 5) Nakamura M, Umetsu R, Abe J, Matsui T, Ueda N, Kato Y, Sasaoka S, Tahara K, Takeuchi H, Kinosada Y. Analysis of the time-to-onset of osteonecrosis of jaw with bisphosphonate treatment using the data from a spontaneous reporting system of adverse drug events. J. Pharm. Health Care Sci., 1, 34 (2015).

Terms in the title (5)： 日本 ,  医薬品副作用データベース ,  デノスマブ ,  低カルシウム血症 ,  規制措置