메뉴 건너뛰기




Volumn 47, Issue 6, 2009, Pages 391-401

Biosimilarity of HX575 (human recombinant epoetin alfa) and epoetin beta after multiple subcutaneous administration

Author keywords

Biosimilar; Epoetin alfa; Epoetin beta; Erythropoiesis stimulating agents; Pharmacodynamics; Pharmacokinetics; Subcutaneous

Indexed keywords

BINOCRIT; ERYTHROPOIETIN ANTIBODY; HEMOGLOBIN; HX 575; IRON; RECOMBINANT ERYTHROPOIETIN; UNCLASSIFIED DRUG;

EID: 67649967626     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP47391     Document Type: Article
Times cited : (13)

References (27)
  • 1
    • 0035433756 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of epoetin alfa once weekly and three times weekly
    • Cheung W, Minton N, Gunawardena K. Pharmacokinetics and pharmacodynamics of epoetin alfa once weekly and three times weekly. Eur J Clin Pharmacol. 2001; 57: 411-418
    • (2001) Eur J Clin Pharmacol , vol.57 , pp. 411-418
    • Cheung, W.1    Minton, N.2    Gunawardena, K.3
  • 3
    • 85036847040 scopus 로고    scopus 로고
    • Accessed 19 January 2009
    • CMP/ICH/281/95. http://www.emea.europa.eu/pdfs/human/ich/ 028195en.pdf. Accessed 19 January 2009.
    • CMP/ICH/281/95
  • 4
    • 85036846445 scopus 로고    scopus 로고
    • Accessed 19 January 2009
    • CMP/ICH/381/95. http://www.emea.europa.eu/pdfs/human/ich/ 038195en.pdf. Accessed 19 January 2009.
    • CMP/ICH/381/95
  • 5
    • 0030207742 scopus 로고    scopus 로고
    • Baseline hemoglobin as a predictor of risk of transfusion and response to Epoetin alfa in orthopedic surgery patients
    • de Andrade JR, Jove M, Landon G et al. Baseline hemoglobin as a predictor of risk of transfusion and response to Epoetin alfa in orthopedic surgery patients. Am J Orthoped. 1996; 25: 533-542.
    • (1996) Am J Orthoped , vol.25 , pp. 533-542
    • de Andrade, J.R.1    Jove, M.2    Landon, G.3
  • 6
    • 58849101851 scopus 로고
    • Dialyzer urea and creatinine clearances not significantly changed in r-HuEPO treated maintenance hemodialysis (MD) patients
    • Delano BG, Lundin AP, Golansky R et al. Dialyzer urea and creatinine clearances not significantly changed in r-HuEPO treated maintenance hemodialysis (MD) patients. Kidney Int. 1988; 33: 219.
    • (1988) Kidney Int , vol.33 , pp. 219
    • Delano, B.G.1    Lundin, A.P.2    Golansky, R.3
  • 7
    • 0000416427 scopus 로고
    • Pharmacokinetics of recombinant human erythropoietin (rHuEPO) administered to hemodialysis (HD) patients
    • Egrie JC, Eschbach JW, McGuire T et al. Pharmacokinetics of recombinant human erythropoietin (rHuEPO) administered to hemodialysis (HD) patients. Kidney Int. 1988; 33: 262.
    • (1988) Kidney Int , vol.33 , pp. 262
    • Egrie, J.C.1    Eschbach, J.W.2    McGuire, T.3
  • 8
    • 84919843692 scopus 로고    scopus 로고
    • Accessed 19 January 2009
    • EMEA/CHMP/BWP/49348/2005. Accessed 19 January 2009: http://www.emea.europa.eu/pdfs/human/biosimilar/4934805en.pdf.
    • EMEA/CHMP/BWP/49348/2005
  • 9
    • 0024790160 scopus 로고
    • Recombinant human erythropoietin in anemic patients with end-stage renal disease. Results of a phase III multicenter clinical trial
    • Eschbach JW, Abdulhadi MH, Browne JK et al. Recombinant human erythropoietin in anemic patients with end-stage renal disease. Results of a phase III multicenter clinical trial. Ann Intern Med. 1989; 111: 992-1000.
    • (1989) Ann Intern Med , vol.111 , pp. 992-1000
    • Eschbach, J.W.1    Abdulhadi, M.H.2    Browne, J.K.3
  • 10
    • 0022258403 scopus 로고
    • Anemia of end-stage renal disease (ESRD)
    • Eschbach JW, Adamson JW. Anemia of end-stage renal disease (ESRD). Kidney Int. 1985; 28: 1-5.
    • (1985) Kidney Int , vol.28 , pp. 1-5
    • Eschbach, J.W.1    Adamson, J.W.2
  • 11
    • 0023120533 scopus 로고    scopus 로고
    • Eschbach JW, Egrie JC, DowningMRet al. Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. Results of a combined phase I and II clinical trial. N Engl J Med. 1987; 316: 73-78.
    • Eschbach JW, Egrie JC, DowningMRet al. Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. Results of a combined phase I and II clinical trial. N Engl J Med. 1987; 316: 73-78.
  • 12
    • 0009495870 scopus 로고
    • The use of recombinant human erythropoietin (r-HuEPO): Effect in end-stage renal disease (ESRD)
    • Friedman EA, Beyer M, DeSanto NG, Giordano C eds, Philadelphia, PA: Field and Wood Inc
    • Eschbach JW, Egrie JC, Downing MR et al. The use of recombinant human erythropoietin (r-HuEPO): Effect in end-stage renal disease (ESRD). In: Friedman EA, Beyer M, DeSanto NG, Giordano C (eds). Prevention of chronic uremia. Philadelphia, PA: Field and Wood Inc., 1989. p.148-155.
    • (1989) Prevention of chronic uremia , pp. 148-155
    • Eschbach, J.W.1    Egrie, J.C.2    Downing, M.R.3
  • 13
    • 0025190665 scopus 로고
    • The quality of life of hemodialysis recipients treated with recombinant human erythropoietin
    • Evans RW, Rader B, Manninen DL. The quality of life of hemodialysis recipients treated with recombinant human erythropoietin. JAMA. 1990; 263: 825-830.
    • (1990) JAMA , vol.263 , pp. 825-830
    • Evans, R.W.1    Rader, B.2    Manninen, D.L.3
  • 14
    • 0345593589 scopus 로고    scopus 로고
    • The effects of recombinant human erythropoietin on perioperative transfusion requirements in patients having a major orthopaedic operation
    • Faris PM, Ritter MA, Abels RI. The effects of recombinant human erythropoietin on perioperative transfusion requirements in patients having a major orthopaedic operation. J Bone Joint Surg Am. 1996; 78: 62-72.
    • (1996) J Bone Joint Surg Am , vol.78 , pp. 62-72
    • Faris, P.M.1    Ritter, M.A.2    Abels, R.I.3
  • 15
    • 85036803583 scopus 로고    scopus 로고
    • FDA Guidance for industry bioanalytical method validation. May, Accessed 19 January 2009
    • FDA Guidance for industry bioanalytical method validation. May 2001. Accessed 19 January 2009: http://www.fda.gov/CDER/GUIDANCE/ 4252fnl.htm.
    • (2001)
  • 16
    • 54049083072 scopus 로고    scopus 로고
    • Safety update on erythropoiesis-stimulating agents: Trials within and outside the accepted indications
    • Gascón P. Safety update on erythropoiesis-stimulating agents: trials within and outside the accepted indications. Oncologist. 2008; 13 (Suppl. 3): 4-10.
    • (2008) Oncologist , vol.13 , Issue.SUPPL. 3 , pp. 4-10
    • Gascón, P.1
  • 17
    • 0030208534 scopus 로고    scopus 로고
    • A safety and efficacy comparison of two dosing regimens of epoetin alfa in patients undergoing major orthopedic surgery
    • Goldberg MA, McCutchen JW, Jove M et al. A safety and efficacy comparison of two dosing regimens of epoetin alfa in patients undergoing major orthopedic surgery. Am J Orthoped. 1996; 25: 544-552.
    • (1996) Am J Orthoped , vol.25 , pp. 544-552
    • Goldberg, M.A.1    McCutchen, J.W.2    Jove, M.3
  • 18
    • 0017909526 scopus 로고
    • Erythropoietin and the control of red cell production
    • Graber SE, Krantz SB. Erythropoietin and the control of red cell production. Annu Rev Med. 1978; 29: 51-66.
    • (1978) Annu Rev Med , vol.29 , pp. 51-66
    • Graber, S.E.1    Krantz, S.B.2
  • 19
    • 0026355305 scopus 로고
    • Comparative pharmacokinetics and pharmacodynamics of epoetin alfa and epoetin beta
    • Halstenson CE, Macres M, Katz SA et al. Comparative pharmacokinetics and pharmacodynamics of epoetin alfa and epoetin beta. Clin Pharmacol Ther. 1991; 50: 702-712.
    • (1991) Clin Pharmacol Ther , vol.50 , pp. 702-712
    • Halstenson, C.E.1    Macres, M.2    Katz, S.A.3
  • 20
    • 0001961705 scopus 로고
    • A distribution-free procedure for the statistical analysis of bioequivalence studies
    • Hauschke D, Steinijans VW, Diletti E. A distribution-free procedure for the statistical analysis of bioequivalence studies. Int J Clin Pharmacol Ther Toxicol. 1992; 30 (Suppl. 1): 37-43.
    • (1992) Int J Clin Pharmacol Ther Toxicol , vol.30 , Issue.SUPPL. 1 , pp. 37-43
    • Hauschke, D.1    Steinijans, V.W.2    Diletti, E.3
  • 21
    • 85036811507 scopus 로고    scopus 로고
    • Hollander M, Wolfe DA. Nonparametric statistical methods. The two sample problem.NewYork:Wiley, 1973.
    • Hollander M, Wolfe DA. Nonparametric statistical methods. The two sample problem.NewYork:Wiley, 1973.
  • 22
    • 0024581871 scopus 로고
    • Recombinant human erythropoietin treatment in predialysis patients: A double-blind placebo-controlled trial
    • Lim VS, DeGowin RL, Zavala D et al. Recombinant human erythropoietin treatment in predialysis patients: A double-blind placebo-controlled trial. Ann Int Med. 1989; 110: 108-114.
    • (1989) Ann Int Med , vol.110 , pp. 108-114
    • Lim, V.S.1    DeGowin, R.L.2    Zavala, D.3
  • 23
    • 49249119764 scopus 로고    scopus 로고
    • Erythropoiesis-stimulating agents: Benefits and risks in supportive care of cancer
    • Melosky BL. Erythropoiesis-stimulating agents: benefits and risks in supportive care of cancer. Curr Oncol. 2008; 15 (Suppl. 1): S10-S15.
    • (2008) Curr Oncol , vol.15 , Issue.SUPPL. 1
    • Melosky, B.L.1
  • 24
    • 0036280663 scopus 로고    scopus 로고
    • Randomized, controlled trial of darbepoetin alfa for the treatment of anemia in hemodialysis patients
    • Nissenson AR, Swan SK, Lindberg JS et al. Randomized, controlled trial of darbepoetin alfa for the treatment of anemia in hemodialysis patients. Am J Kidney Dis. 2002; 40: 110-118.
    • (2002) Am J Kidney Dis , vol.40 , pp. 110-118
    • Nissenson, A.R.1    Swan, S.K.2    Lindberg, J.S.3
  • 25
    • 9244248547 scopus 로고
    • Clinical sequelae of correction of anemia with recombinant human erythropoietin (r-HuEPO); Urea kinetics, dialyzer function and reuse
    • Paganini E, Garcia J, Ellis P et al. Clinical sequelae of correction of anemia with recombinant human erythropoietin (r-HuEPO); Urea kinetics, dialyzer function and reuse. Am J Kidney Dis. 1988; 11: 16.
    • (1988) Am J Kidney Dis , vol.11 , pp. 16
    • Paganini, E.1    Garcia, J.2    Ellis, P.3
  • 26
    • 58849123396 scopus 로고
    • Use of recombinant erythropoietin (r-HuEPO) with high flux dialysis (HFD) does not worsen azotemia or shorten access survival
    • Stivelman J, Van Wyck D, Ogden D. Use of recombinant erythropoietin (r-HuEPO) with high flux dialysis (HFD) does not worsen azotemia or shorten access survival. Kidney Int. 1988; 33: 239.
    • (1988) Kidney Int , vol.33 , pp. 239
    • Stivelman, J.1    Van Wyck, D.2    Ogden, D.3
  • 27
    • 0023806006 scopus 로고
    • Treatment of the anemia of pre-dialysis patients with recombinant human erythropoietin: A randomized, placebo-controlled trial
    • Stone WJ, Graber SE, Krantz SB et al. Treatment of the anemia of pre-dialysis patients with recombinant human erythropoietin: A randomized, placebo-controlled trial. Am J Med Sci. 1988; 296: 171-179.
    • (1988) Am J Med Sci , vol.296 , pp. 171-179
    • Stone, W.J.1    Graber, S.E.2    Krantz, S.B.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.