메뉴 건너뛰기




Volumn 32, Issue 11, 2010, Pages 1968-1976

Pharmacokinetic and pharmacodynamic comparison of two recombinant human erythropoietin formulations after single subcutaneous administration: An open-label, sequence-randomized, two-treatment crossover study in healthy Korean male volunteers

Author keywords

LBEP0202; Pharmacodynamics; Pharmacokinetics; Recombinant human erythropoietin

Indexed keywords

ERYTHROPOIETIN; LBEP 0202; RECOMBINANT ERYTHROPOIETIN; UNCLASSIFIED DRUG;

EID: 78649364413     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2010.10.001     Document Type: Article
Times cited : (5)

References (17)
  • 1
    • 78649351842 scopus 로고    scopus 로고
    • Anemia of chronic renal failure
    • McGraw- Hill, Medical Pub. Division, New York, NY, Chapter 35, M.A. Lichtman (Ed.)
    • Caro J Anemia of chronic renal failure. Williams Hematology 2006, McGraw- Hill, Medical Pub. Division, New York, NY, Chapter 35. 7th ed. M.A. Lichtman (Ed.).
    • (2006) Williams Hematology
    • Caro, J.1
  • 2
    • 78649371643 scopus 로고    scopus 로고
    • Hematopoietic agents: Growth factors, minerals, and vitamins
    • McGraw-Hill Medical, New York, NY, Chapter 53, L.L. Brunton, K.L. Parker, D.K. Blumenthal, I.L. Buxton (Eds.)
    • Kaushansky K, Kipps TJ Hematopoietic agents: Growth factors, minerals, and vitamins. Goodman & Oilman's Manual of Pharmacology and Therapeutics 2008, McGraw-Hill Medical, New York, NY, Chapter 53. 11th ed. L.L. Brunton, K.L. Parker, D.K. Blumenthal, I.L. Buxton (Eds.).
    • (2008) Goodman & Oilman's Manual of Pharmacology and Therapeutics
    • Kaushansky, K.1    Kipps, T.J.2
  • 3
    • 0023120533 scopus 로고
    • Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. Results of a combined phase I and II clinical trial
    • Eschbach JW, Egrie JC, Downing MR, et 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.
    • (1987) N Engl J Med. , vol.316 , pp. 73-78
    • Eschbach, J.W.1    Egrie, J.C.2    Downing, M.R.3
  • 4
    • 70349525416 scopus 로고    scopus 로고
    • Amgen Inc, Thousand Oaks, Calif, Accessed December 3, 2009
    • Procrit (epoetin alfa) [package insert] 2008, Amgen Inc, Thousand Oaks, Calif, Accessed December 3, 2009. http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103234s5164lbl.pdf.
    • (2008) Procrit (epoetin alfa) [package insert]
  • 5
    • 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
  • 6
    • 4143136302 scopus 로고    scopus 로고
    • Pharmacokinetic and pharmacodynamic modeling of recombinant human erythropoietin after single and multiple doses in healthy volunteers
    • Ramakrishnan R, Cheung WK, Wacholtz MC, et al. Pharmacokinetic and pharmacodynamic modeling of recombinant human erythropoietin after single and multiple doses in healthy volunteers. J Clin Pharmacol. 2004, 44:991-1002.
    • (2004) J Clin Pharmacol. , vol.44 , pp. 991-1002
    • Ramakrishnan, R.1    Cheung, W.K.2    Wacholtz, M.C.3
  • 7
    • 78649336384 scopus 로고    scopus 로고
    • R&D Systems Inc, Minneapolis, Minn, Accessed December 4, 2009
    • Quantikine IVD Human EPO EIA kit [package insert] 2009, R&D Systems Inc, Minneapolis, Minn, Accessed December 4, 2009. http://www.rndsystems.com/pdf/dep00.pdf.
    • (2009) Quantikine IVD Human EPO EIA kit [package insert]
  • 10
    • 0003922013 scopus 로고    scopus 로고
    • US Dept of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research, Accessed September 27, 2010.
    • Guidance for Industry: Statistical Approaches to Establishing Bioequivalence US Dept of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research, Accessed September 27, 2010. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf.
    • Guidance for Industry: Statistical Approaches to Establishing Bioequivalence
  • 11
    • 4444383113 scopus 로고    scopus 로고
    • A comparison of the bioequivalence of two formulations of epoetin alfa after subcutaneous injection
    • Togawa A, Tanaka T, Nagashima S, et al. A comparison of the bioequivalence of two formulations of epoetin alfa after subcutaneous injection. Br J Clin Pharmacol. 2004, 58:269-276.
    • (2004) Br J Clin Pharmacol. , vol.58 , pp. 269-276
    • Togawa, A.1    Tanaka, T.2    Nagashima, S.3
  • 12
    • 0034448232 scopus 로고    scopus 로고
    • Comparative pharmacokinetics, safety, and tolerability after subcutaneous administration of recombinant human erythropoietin formulated with different stabilizers
    • Cheung WK, Natarajan J, Sanders M, Vercammen E Comparative pharmacokinetics, safety, and tolerability after subcutaneous administration of recombinant human erythropoietin formulated with different stabilizers. Biopharm Drug Dispos. 2000, 21:211-219.
    • (2000) Biopharm Drug Dispos. , vol.21 , pp. 211-219
    • Cheung, W.K.1    Natarajan, J.2    Sanders, M.3    Vercammen, E.4
  • 13
    • 0027731561 scopus 로고
    • Diurnal variations of serum erythropoietin in trained and untrained subjects
    • Klausen T, Dela F, Hippe E, Galbo H Diurnal variations of serum erythropoietin in trained and untrained subjects. Eur J Appl Physiol Occup Physiol. 1993, 67:545-548.
    • (1993) Eur J Appl Physiol Occup Physiol. , vol.67 , pp. 545-548
    • Klausen, T.1    Dela, F.2    Hippe, E.3    Galbo, H.4
  • 15
    • 23244463549 scopus 로고    scopus 로고
    • Comparison of two recombinant erythropoietin formulations in patients with anemia due to end-stage renal disease on he- modialysis: A parallel, randomized, double blind study
    • Bioequivalence Study of Erythropoietin Group
    • Pérez-Oliva JF, Casanova-Gonzalez M, Garcfa-Garcfa I, et al. Comparison of two recombinant erythropoietin formulations in patients with anemia due to end-stage renal disease on he- modialysis: A parallel, randomized, double blind study. BMC Nephrol. 2005, 6:5. Bioequivalence Study of Erythropoietin Group.
    • (2005) BMC Nephrol. , vol.6 , pp. 5
    • Pérez-Oliva, J.F.1    Casanova-Gonzalez, M.2    Garcfa-Garcfa, I.3
  • 16
    • 34548077901 scopus 로고    scopus 로고
    • Interspecies comparisons of pharmacokinetics and pharmacodynamics of recombinant human erythropoietin
    • Woo S, Jusko WJ Interspecies comparisons of pharmacokinetics and pharmacodynamics of recombinant human erythropoietin. Drug Metab Dispos. 2007, 35:1672-1678.
    • (2007) Drug Metab Dispos. , vol.35 , pp. 1672-1678
    • Woo, S.1    Jusko, W.J.2
  • 17
    • 62949147825 scopus 로고    scopus 로고
    • Guide-line on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins. Accessed July 14, 2010.
    • European Medicines Agency Guide-line on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins. Accessed July 14, 2010. http://www.ema.europa.eu/pdfs/human/biosimilar/30163608enfin.pdf.
    • European Medicines Agency


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.