M. Audran(1) , F. Bressolle (2), R. Gareau (3) and R. Gomeni (4)
(1) Depart. Biophysics, Fac. Pharmacy, Univ. Montpellier I, France (2) Depart. Pharmacokin., Fac. Pharmacy, Univ. Montpellier I, France, (3) Lab. Biological-Chemistry, Univ. Quebec, Trois Rivieres, Canada, (4) BESTFIT, Luxembourg
The pharmacokinetic parameters of recombinant human erythropoietin (rHuEpo) were initially determined in healthy volunteers after a single subcutaneous administration of rHuEpo (50u/kg). Then 30 athletes were included in second part of the study. Twenty subjects received repeated subcutaneous administrations of high dose (200 u/kg) of rHuEpo and 10 subjects received placebo. Erythropoietin concentrations returned to normal values in serum and urine, 7 and 4 days after the last administration, respectively. Significant changes in reticulocytes, red blood cells, haemoglobin concentration and haematocrit were observed after administration of rHuEpo. In the control group, these parameters remained unchanged. The change in reticulocytes was used as an index of the therapeutic effect of rHuEpo. A comparative population Pk-Pd analysis was performed on the basis of the indirect pharmacodynamic responses models and the compartimental modeling approach to evaluate the more appropriate model suitable to describe concentration-effect relationships. A parametric, non-parametric and semi-parametric models has been used to estimate the Erythropoietin in the effect site.
Reference: PAGE 5 () Abstr 553 [www.page-meeting.org/?abstract=553]
Poster: oral presentation