Biology Reference
In-Depth Information
Table 3. (continued)
Ref
IV Dose (U/kg)
CL (mL/hr/kg)
t
1/2,z
(hr)
n
[14]
25-225
15
8.1
f
6.9 (SEM 0.8)
[4-44]
[8]
50 (non-naive),
9.7
g
5.4 (0.9)
4
[epoetin beta]
150 (naive)
5.1
h
7.6
2
[epoetin beta]
9.8
f
[9]
24, 48
5.3 (1.3)
6
[epoetin alfa]
[33]
100
6 HD
6.0
NA
[epoetin beta]
100
6 CAPD
NA
6.1
[epoetin beta]
[1]
50
12
10.09 (3.54)
5.40 (1.7)
[epoetin alfa]
[2]
40
13.5
i
6.67 (1.18)
8
[epoetin beta]
7.26
[34]
3000 U
3
9.99 (SEM 1.59)
[epoetin beta]
6000 U]
5.84
10.41 (SEM 0.79)
4
[epoetin beta]
9000 U
NA
3
NA
[epoetin beta]
[13]
100
8
k
4.8
c
7.91 (4.2)
[epoetin alfa]
8.23
b
[6.05-13.7]
[18]
100
4.3
l
12
[epoetin beta]
Values given as mean (SD) [range] unless otherwise indicated. CL, clearance; IV, intravenous; NA,
not available; n, number of subjects; SEM, standard error of the mean.
a
recalculated from median clearance in mL/min using median body weight (57 kg); *60/57.
b
medi-
an.
c
calculated from clearance in mL/min/kg by *60.
d
IV data from two groups reported separately.
e
calculated from median AUC using CL = Dose (mU/kg)/AUC (mU*hr/mL).
f
recalculated from
mL/min assuming 70 kg body weight; *60/70.
g
recalculated from mL/min using mean body weight
(60.1 kg); *60/60.1.
h
recalculated from mL/min using mean body weight (86.3 kg); *60/86.3.
i
recal-
culated from mL/min using mean body weight (58.2 kg);*60/58.2.
j
recalculated from mL/hr using
mean IV body weight (50.0 kg).
k
subjects were mixture of EPO-naive and non-EPO naive.
l
recalcu-
lated from median value in L/hr per 1.73 m
2
by *(1000/70).
Multiple dose
Studies comparing single-dose and multiple-dose pharmacokinetics, as
reflects clinical practice, have generally found that the pharmacokinetic prop-
erties change to a limited degree upon multiple dosing; these studies are sum-
marized in Table 4. Most studies have found that clearance increases and/or
terminal half-life decreases after multiple dosing [1, 25, 28, 31]. Additionally,
