Pharmacokinetic and Pharmacodynamic Comparison of Two Recombinant Human Erythropoietin Formulations, PDA10 and Eprex, in Healthy Korean Male Volunteers: A Randomized, Double-Blinded, Single-Dose, Two-Period Crossover Study-Reference-Cited by-同舟云学术

Pharmacokinetic and Pharmacodynamic Comparison of Two Recombinant Human Erythropoietin Formulations, PDA10 and Eprex, in Healthy Korean Male Volunteers: A Randomized, Double-Blinded, Single-Dose, Two-Period Crossover Study

Published:2015-09-14 Issue:10 Volume:35 Page:659-664
ISSN:1173-2563
Container-title:Clinical Drug Investigation
language:en
Short-container-title:Clin Drug Investig

Author:

Oh MinKyung,Yoon Jaeseung,Cho Doo-Yeoun

Funder

Ministry of Health & Welfare ROK

PanGen Biotech Inc.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),General Medicine

Link

http://link.springer.com/content/pdf/10.1007/s40261-015-0327-1.pdf

Reference13 articles.

1. Jelkmann W. Erythropoietin: structure, control of production, and function. Physiol Rev. 1992;72:449–89.

2. Graber SE, Krantz SB. Erythropoietin: biology and clinical use. Hematol Oncol Clin N Am. 1989;3:369–400.

3. Eschbach JW, Egrie JC, Downing MR, Browne JK, Adamson JW. 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;316:73–8.

4. Ng T, Marx G, Littlewood T, Macdougall I. Recombinant erythropoietin in clinical practice. Postgrad Med J. 2003;79:367–76.

5. Platanias LC, Miller CB, Mick R, Hart RD, Ozer H, McEvilly JM, Jones RJ, Ratain MJ. Treatment of chemotherapy-induced anemia with recombinant human erythropoietin in cancer patients. J Clin Oncol. 1991;9:2021–6.

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