文献

J-GLOBAL ID：201702210568916597   整理番号：17A1371015

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

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

著者 (8件)： 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)
資料名： Biological and Pharmaceutical Bulletin  (Biological and Pharmaceutical Bulletin)
巻： 40  号： 9  ページ： 1447-1453(J-STAGE)  発行年： 2017年 
JST資料番号： S0989A  ISSN： 0918-6158  CODEN： BPBLEO  資料種別： 逐次刊行物 (A)
記事区分： 原著論文  発行国： 日本 (JPN)  言語： 英語 (EN)

抄録/ポイント： 抗核内因子-κB活性化受容体リガンド(RANKL)抗体のデノ...

シソーラス用語： ヒト ,...
準シソーラス用語： *デノスマブ ,...

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著者キーワード (12件)： 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

分類 (2件)： 薬学一般  (GU01010G) ,  代謝異常・栄養性疾患一般  (GD05010J)

引用文献 (22件)：

• 1) Hoffman KB, Dimbil M, Tatonetti NP, Kyle RF. A pharmacovigilance signaling system based on FDA regulatory action and post-marketing adverse event reports. Drug Saf., 39, 561-575 (2016).
• 2) Hauben M, Horn S, Reich L. Potential use of data-mining algorithms for the detection of ‘surprise’ adverse drug reactions. Drug Saf., 30, 143-155 (2007).
• 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).

タイトルに関連する用語 (5件)： 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