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Table 2 Pharmacokinetic parameters calculated from the EPO concentration in serum

From: Comparison of two recombinant erythropoietin formulations in patients with anemia due to end-stage renal disease on hemodialysis: A parallel, randomized, double blind study

Parameter

Formulation A N = 17

Formulation B N = 16

Difference (%)

p

90 % CI

AUC120(mUI·h/mL)

4500 ± 2281

4654 ± 2221

5.1

0.49

(0.71 – 1.27)

AUC (mUI·h/mL)

4667 ± 2319

4918 ± 2113

3.3

0.66

(0.71 – 1.32)

Cmax (mUI/ml)

119.1 ± 56.4

119.7 ± 60.5

0.5

0.96

(0.73 – 1.35)

Tmax (h)

13.9 ± 9.9

18.1 ± 14.9

23.2

0.08

-

λ(h-1)

0.040 ± 0.018

0.037 ± 0.015

10.8

0.49

(0.89 – 1.32)

t1/2 (h)

20.0 ± 7.9

22.5 ± 12.1

11.1

0.29

(0.69 – 1.14)

CAV

0.027 ± 0.008

0.024 ± 0.007

8.0

0.38

(0.94 – 1.31)

F

0.29 ± 0.14

0.31 ± 0.14

6.4

0.53

(0.75 – 1.17)

MRT (h)

33.9 ± 10.7

42.3 ± 20.8

19.8

0.15

-

CL (mL/h·Kg)

6.3 ± 0.3

6.3 ± 0.4

0.5

0.55

(0.98 – 1.03)

Vd (mL/Kg)

182 ± 74

202 ± 107

10.0

0.67

(0.70 – 1.15)

  1. Data are reported as mean ± standard deviation
  2. CI: confidence intervals of the mean ratio; for Tmax and MRT, 90 %CI could not be estimated for a parallel design.
  3. p: ANOVA between groups