Evaluation of Safety in Clinical Use of Generic Paclitaxel [NK] for Injection

TSUKIYAMA Ikuto; HOTTA Kazuo; TAKEUCHI Masayuki; ONISHI Masahumi; TOYAMA Yukio; SAITO Hiroko; SAI Yoshimichi; MIYAMOTO Ken-Ichi; HASEGAWA Takaaki

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J-GLOBAL ID：201202201555818559 Reference number：12A0652715

Evaluation of Safety in Clinical Use of Generic Paclitaxel [NK] for Injection

注射用ジェネリックパクリタキセル[NK]の臨床使用における安全性評価

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Material：
Volume： 39 Issue： 4 Page： 613-617 Publication year： Apr. 15, 2012
JST Material Number： Z0938A ISSN： 0385-0684 Document type： Article
Article type：原著論文 Country of issue： Japan (JPN) Language： ENGLISH (EN)

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Reference (7)：

1) National Institute of Health Science, Japan. Guideline of Bioequivalence Test of Generic Drug. http://www.nihs.go.jp/drug/be-guide(e)/Generic/be97E.pdf (accessed 2008 September 1st)
2) Rai Y, Arai S, Ohata H, Sagara Y, et al: Comparative study of compatibility and quality between Paclitaxel injection 100 mg/16. 7 mL [NK] and Taxol^® injection 100 mg/16. 7 mL. Jpn J Med Pharm Sci 57: 319-324, 2007.
3) Interview form of Taxol^® Injection (in Japanese) : Bristol-Myers Squibb Co. LTD 2008; 5: 50.
4) Goda R, Yamaguchi T, Yamashita T, et al: Plasma concentration in dogs, compatibility and drip rate of Paclitaxel Inj. 30 mg/5 mL [NK]. Jpn J Med Pharm Sci 56: 563-570, 2006.
5) Sagara Y, Rai Y, Sagara Y, et al: Comparison of the pharmacokinetics and safety of a paclitaxel injection NK and Taxol^® injection in breast cancer patients. Gan To Kagaku Ryoho 36 (2) : 247-250, 2009. (in Japanese)

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