Development of an S-1 dosage formula based on renal function by a prospective pharmacokinetic study

Author:

Booka Eisuke,Imamura Chiyo K.,Takeuchi Hiroya,Hamamoto Yasuo,Gomi Daisuke,Mizukami Takuro,Ichiyama Takashi,Tateishi Kazunari,Takahashi Tsunehiro,Kawakubo Hirofumi,Soejima Kenzo,Boku Narikazu,Tanigawara Yusuke,Kitagawa Yuko

Publisher

Springer Science and Business Media LLC

Subject

Cancer Research,Gastroenterology,Oncology,General Medicine

Reference33 articles.

1. US Food Drug Administration. Guidance for industry: pharmacokinetics in patients with impaired renal function—study design, data analysis, and impact on dosing and labeling. 2010. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072127.pdf . Accessed 21 July 2015.

2. European Medicines Agency. Note for guidance on the evaluation of the pharmacokinetics of medical products in patients with renal function. 2004. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003123.pdf . Accessed 21 July 2015.

3. Heidelberger C, Chaudhuri NK, Danneberg P, Mooren D, Griesbach L, Duschinsky R, et al. Fluorinated pyrimidines, a new class of tumour-inhibitory compounds. Nature. 1957;179:663–6.

4. Shirasaka T, Nakano K, Takechi T, Satake H, Uchida J, Fujioka A, et al. Antitumor activity of 1 M tegafur-0.4 M 5-chloro-2,4-dihydroxypyridine-1 M potassium oxonate (S-1) against human colon carcinoma orthotopically implanted into nude rats. Cancer Res. 1996;56:2602–6.

5. Shirasaka T, Shimamato Y, Ohshimo H, Yamaguchi M, Kato T, Yonekura K, et al. Development of a novel form of an oral 5-fluorouracil derivative (S-1) directed to the potentiation of the tumor selective cytotoxicity of 5-fluorouracil by two biochemical modulators. Anticancer Drugs. 1996;7:548–57.

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