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Pharmacokinetics and Pharmacodynamics of Recombinant Human Erythropoietin After Single and Multiple Subcutaneous Doses to Healthy Subjects* by Wing K. Cheung; Betty L. Goon; Mary C. Guilfoyle; Mary C. Wacholtz is a Medicine article available to read on EtoBox.

What is Pharmacokinetics and Pharmacodynamics of Recombinant Human Erythropoietin After Single and Multiple Subcutaneous Doses to Healthy Subjects* about?

Pharmacokinetics and pharmacodynamics of recombinant human erythropoietin after single and multiple subcutaneous doses to healthy subjects Objectives: To understand the pharmacokinetic and pharmacodynamic properties of recombinant human erythropoietin (epoetin alfa) and to continue to optimize dosing regimens by determining whether administration of single high doses of epoetin alfa is as effective as repeated administration. Methods: Epoetin alfa was administered as single subcutaneous doses of 300,450, 600, 900, 1200, 1350, 1800, and 2400 IV/kg and in multiple subcutaneous dose regimens: 150 IV/kg 3 times a week for 4 weeks and 600 IU/kg once per week for 4 weeks in 2 open-label, randomized placebo-controlled studies in healthy volunteers. Results: The absorption rate of epoetin alfa after subcutaneous administration was independent of dose, whereas clearance was dose-dependent in that it decreased with increasing dose. There was a linear relationship between response measured as percentage of reticulocytes area under the curve (AUC) and erythropoietin AUC for single doses up to 1800 IU/kg. Beyond the 1800 IV/kg dose, there was a saturation of response. The mean percentage of ret

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Author

Wing K. Cheung; Betty L. Goon; Mary C. Guilfoyle; Mary C. Wacholtz

Publisher

Nature Publishing Group; Wiley (Blackwell Publishing); Wiley-Blackwell; Wiley; Springer Science and Business Media LLC; Research Square (ISSN 0009-9236)

Published

1998

Language

EN

Field

Medicine (Health Sciences)