Pharmacokinetic and Pharmacodynamic Profile of New Biosimilar Filgrastim XM02 Equivalent to Marketed Filgrastim Neupogen®
作者： Heinz Lubenau , Peter Bias , Anne-Katrin Maly , Karl Ernst Siegler , Kai Mehltretter
DOI: 10.2165/00063030-200923010-00005
关键词: Clinical trial 、 Filgrastim 、 Pharmacology 、 Biosimilar 、 Crossover study 、 Neutropenia 、 Pharmacodynamics 、 Absolute neutrophil count 、 Pharmacokinetics 、 Biotechnology 、 Pharmacology (medical) 、 General Medicine
摘要: Objective Filgrastim XM02 is a biosimilar non-glycosylated recombinant methionyl form of human granulocyte colony-stimulating factor (r-MetHuG-CSF) expressed in Escherichia coli for subcutaneous and intravenous administration the treatment different forms neutropenia stem cell mobilization. This study was conducted to compare pharmacokinetic pharmacodynamic characteristics new filgrastim with marketed (Neupogen®).
springer.com
sci-hub.se 参考文章(16)
Bing Wang, Thomas M. Ludden, Ellen N. Cheung, Gisela G. Schwab, Lorin K. Roskos, Population pharmacokinetic-pharmacodynamic modeling of filgrastim (r-metHuG-CSF) in healthy volunteers. Journal of Pharmacokinetics and Pharmacodynamics. ,vol. 28, pp. 321- 342 ,(2001) , 10.1023/A:1011534529622
Gerhard Nahler, Committee for Proprietary Medicinal Products (CPMP) Dictionary of Pharmaceutical Medicine. pp. 32- 32 ,(2009) , 10.1007/978-3-211-89836-9_243
J. Singh, European medicines evaluation agency Indian Journal of Pharmacology. ,vol. 36, pp. 52- ,(2004)
D. ROBERT SUTHERLAND, LORI ANDERSON, MICHAEL KEENEY, RAKASH NAYAR, IAN CHIN-YEE, The ISHAGE guidelines for CD34+ cell determination by flow cytometry. International Society of Hematotherapy and Graft Engineering. Journal of hematotherapy. ,vol. 5, pp. 213- 226 ,(1996) , 10.1089/SCD.1.1996.5.213
MH Bronchud, MR Potter, G Morgenstern, MJ Blasco, JH Scarffe, N Thatcher, D Crowther, LM Souza, NK Alton, NG Testa, TM Dexter, In vitro and in vivo analysis of the effects of recombinant human granulocyte colony-stimulating factor in patients. British Journal of Cancer. ,vol. 58, pp. 64- 69 ,(1988) , 10.1038/BJC.1988.163
Francisco Hernández-Bernal, Idrian García-García, Carlos A. González-Delgado, Carmen Valenzuela-Silva, Ramón Soto-Hernández, Jorge Ducongé, Majel Cervantes-Llano, Elizabeth Blanco-Garcés, Víctor Rodríguez, Yanelda García-Vega, Iraldo Bello-Rivero, Lourdes Olivera-Ruano, Pedro López-Saura, Bioequivalence of two recombinant granulocyte colony-stimulating factor formulations in healthy male volunteers. Biopharmaceutics & Drug Disposition. ,vol. 26, pp. 151- 159 ,(2005) , 10.1002/BDD.445
Michael Keeney, Jan W. Gratama, D. Robert Sutherland, Critical role of flow cytometry in evaluating peripheral blood hematopoietic stem cell grafts Cytometry Part A. ,vol. 58, pp. 72- 75 ,(2004) , 10.1002/CYTO.A.10103
H. Lubenau, A. Sveikata, G. Gumbrevicius, J. Macijauskiene, V. Fokas, S. Kazlauskas, V. Janulionis, Bioequivalence of two recombinant granulocyte colony-stimulating factor products after subcutaneous injection in healthy volunteers. principles and practice of constraint programming. ,vol. 47, pp. 275- 282 ,(2009) , 10.5414/CPP47275
Yoshito Kaziro, Tatsumi Yamazaki, Osami Yamamoto, Yuichi Hirata, Naoki Kubota, Masayoshi Oheda, Hitoshi Nomura, Masayoshi Ono, Shigekazu Nagata, Masayuki Tsuchiya, Shigetaka Asano, Molecular cloning and expression of cDNA for human granulocyte colony-stimulating factor. Nature. ,vol. 319, pp. 415- 418 ,(1986) , 10.1038/319415A0
A. W. Roberts, E. DeLuca, D. Metcalf, C. G. Begley, R. Basser, A. P. Grigg, Broad inter‐individual variations in circulating progenitor cell numbers induced by granulocyte colony‐stimulating factor therapy Stem Cells. ,vol. 13, pp. 512- 516 ,(1995) , 10.1002/STEM.5530130508