207
Views
1
CrossRef citations to date
0
Altmetric
Research Article

Pharmacokinetics and pharmacodynamics of FSK0808 and Gran after single intravenous drip administration or single subcutaneous administration: comparative study in healthy Japanese adult male subjects

, , , , , , , , , , , , & show all
Pages 470-475 | Received 23 Jul 2013, Accepted 27 Dec 2013, Published online: 28 Jan 2014

References

  • Nomura H, Imazeki I, Oheda M, et al. Purification and characterization of human granulocyte colony-stimulating factor (G-CSF). EMBO J 1986;5:871–6
  • Gran® Injection 75 150 M300 Gran® Syringe 75 150 M300 interview forms (17th edition). Kyowa Hakko Kirin Co., Ltd. (revised June 2010)
  • Dührsen U, Villeval JL, Boyd J, et al. Effects of recombinant human colony-stimulating factor on hematopoietic progenitor cells in cancer patients. Blood 1988;72:2074–81
  • Sheridan WP, Begley CG, Juttner CA, et al. Effect of peripheral blood progenitor cells mobilised by filgrastim (G-CSF) on platelet recovery after high dose chemotherapy. Lancet 1992;339:640–4
  • Grigg AP, Roberts AW, Raunow H, et al. Optimizing dose and scheduling of filgrastim (granulocyte colony-stimulating factor) for mobilization and collection of peripheral blood progenitor cells in normal volunteers. Blood 1995;86:4437–45
  • Guidelines on peripheral stem cell mobilization and collection from healthy donors for allogeneic peripheral blood stem cell transplantation. Revised 4th edition (June 30, 2010)
  • Guidelines for the quality, safety and efficacy assurance of follow-on biologics. Yakushoku shinsahatu 0304007, Ministry of Health, Labour and Welfare, Japan (March 4, 2009)
  • Guidelines on bioequivalence studies for generic drugs. Iyakushin 487, Ministry of Health, Labour and Welfare, Japan (December 22, 1997)
  • Assessment report for TEVAGRASTIM. (2008). European Medicines Agency, Procedure No. EMEA/H/C/827
  • Gascon P. Presently available biosimilars in hematology-oncology: G-CSF. Targeted Oncol 2012;7:S29–34
  • Waller CF, Bronchud M, Mair S, Challand R. Comparison of the pharmacodynamic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial. Ann Hematol 2010;89:971–8
  • Skrlin A, Radic I, Vuletic M, et al. Comparison of the physicochemical properties of a biosimilar filgrastim with those of reference filgrastim. Biologicals 2010;38:557–66
  • Soergel F, Lerch H, Lauber T. Physicochemical and biologic comparability of a biosimilar granulocyte colony-stimulating factor with its reference product. BioDrugs 2010;24:347–57
  • Krzyzanski W, Wiczling P, Lowe P, et al. Population modeling of filgrastim PK-PD in healthy adults following intravenous and subcutaneous administrations. J Clin Pharmacol 2010;50:101S–12S
  • Scholz M, Schirm S, Wetzler M, et al. Pharmacokinetic and -dynamic modelling of G-CSF derivatives in humans. Theor Biol Med Model 2012;9:32
  • Ohta K, Masuzawa Y, Hirai M, et al. Two patients showing shock-like symptoms due to administration of rhG-CSF. Int J Hematol 1994;54:228
  • Vogel WH. Infusion reactions: diagnosis, assessment, and management. Clin J Oncol Nurs 2010;14:E10–21
  • Hasegawa S, Miyake J, Shioi Y, et al. Comparative studies of pharmacokinetic profiles of biosimilar filgrastim TKN732 and marketed filgrastim Gran. Jpn Phrmacol Ther 2013;41:251–60
  • Hasegawa S, Miyake J, Shioi Y, et al. Comparative studies of pharmacodynamic profiles of biosimilar filgrastim TKN732 and marketed filgrastim gran. Jpn Phrmacol Ther 2013;41:261–74
  • Sagara Y, Sato K, Fukuma E, et al. The efficacy and safety of FSK0808, Filgrastim Biosimilar: a multicenter, non-randomized study in Japanese patients with breast cancer. Jpn J Clin Oncol 2013;43:865–73

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.