Pharmacokinetic and Pharmacodynamic Modeling of Recombinant Human Erythropoietin After Single and Multiple Doses in Healthy Volunteers

2004 ◽  
Vol 44 (9) ◽  
pp. 991-1002 ◽  
Author(s):  
Rohini Ramakrishnan ◽  
Wing K. Cheung ◽  
Mary C. Wacholtz ◽  
Neil Minton ◽  
William J. Jusko
2016 ◽  
Vol 38 (1) ◽  
pp. 53-65 ◽  
Author(s):  
Randall Hoover ◽  
Thomas Hunt ◽  
Michael Benedict ◽  
Susan K. Paulson ◽  
Laura Lawrence ◽  
...  

Blood ◽  
1990 ◽  
Vol 76 (9) ◽  
pp. 1718-1722 ◽  
Author(s):  
FG McMahon ◽  
R Vargas ◽  
M Ryan ◽  
AK Jain ◽  
RI Abels ◽  
...  

A double-blind, placebo-controlled study of the pharmacokinetics and safety of multiple doses of recombinant human erythropoietin [rHuEPO 150 or 300 U/kg either by intravenous (IV) bolus or subcutaneously (SC)] in normal male subjects demonstrated that rHuEPO had a dose- related effect on the hematocrit independent of the route of administration and that multiple doses of rHuEPO had no direct pressor effects. When rHuEPO was injected IV, a monoexponential decrease in serum EPO level was evident for 18 to 24 hours postdose. Absorption of SC injected rHuEPO occurred more slowly, with relatively low serum EPO levels being maintained for 48 hours. All rHuEPO antibody titer determinations were negative. With the exception of significant increases in hemoglobin and hematocrit, no clinically significant changes occurred. No hypertensive, convulsive, or thrombotic events were observed. Of the adverse experiences observed in 10 subjects, none was considered clinically significant, and none of the subjects dropped out because of adverse experiences.


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Sergey Shcherbinin ◽  
Paul Goldsmith ◽  
Krista M Phipps ◽  
Kevin Biglan ◽  
...  

1998 ◽  
Vol 15 (6) ◽  
pp. 523-529 ◽  
Author(s):  
BTJ van den Berg ◽  
RT Louwerse ◽  
GJHM Luiken ◽  
RE Jonkers ◽  
CJ van Boxtel

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Vol 52 (2) ◽  
pp. 195-203 ◽  
Author(s):  
SeungHwan Lee ◽  
Bo-Hyung Kim ◽  
Won-Seok Nam ◽  
Seo Hyun Yoon ◽  
Joo-Youn Cho ◽  
...  

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