Formulation

Statistics

Cmax/dose
(ng/ml/mg)

tmax (day)

AUC0-tlast/dose
(day·µg/ml/mg)

AUC0-inf/dose
(day·µg/ml/mg)

t½
(day)

CL/F
(ml/day)

Vz/F (l)

Omalizumab solution
(n= 73)

Mean ± SD
(CV%)
Range

108.8 ± 30.2
(27.8)
48.0–176.9

5.0a
—
2.0–14.0

3.89 ± 1.08
(27.7)
1.44–6.37

4.26 ± 1.25
(29.4)
1.50–7.33

22.1 ± 3.7
(16.9)
14.8–31.6

260 ± 96
(37.0)
136–667

8.02 ± 2.25
(28.1)
4.69–17.48

Omalizumab powder for solution
(n= 80)

Mean ± SD
(CV%)
Range

106.9 ± 28.3
(26.5)
41.5–175.7

5.0a
—
1.0–14.0

3.92 ± 0.96
(24.6)
1.62–6.09

4.30 ± 1.13
(26.2)
1.77–6.64

22.9 ± 4.2
(18.5)
15.3–34.2

252 ± 82
(32.4)
151–565

8.11 ± 2.27
(27.9)
5.10–18.81
aMedian
Cmax = maximum serum concentration, tmax = time to Cmax, AUC0-tlast = area under the serum concentration time curve from time 0 to the time of the last quantifiable concentration, AUC0-inf = AUC from time 0 to infinity, t½ = apparent terminal elimination half-life, CL/F = apparent total body clearance from serum, Vz/F = apparent volume of distribution during terminal phase, SD = standard deviation, mean = arithmetic mean, CV% = coefficient of variation.
Table 3: Pharmacokinetic parameters of omalizumab in serum after subcutaneous administration of omalizumab solution or omalizumab powder for solution.
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