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. 2019 Dec 3;6:261. doi: 10.3389/fmed.2019.00261

Table 8.

Pharmacokinetic profile of Simoctocog Alfa (dose: 50 IU/Kg) in pediatric, adolescent, and adult PTPs with severe HA (chromogenic substrate assay) (data from product characteristics documentation).

Patient age
Pharmacokinetic parameter 2–5 years
(n = 13)
6–12 years
(n = 12)
18–65 years
(n = 20)
AUC (h*UI/ml) 11.7 ± 5.3 13.2 ± 3.4 22.6 ± 8.0
t 1/2 (h) 9.5 ± 3.3 10.0 ± 1.9 14.7 ± 10.4
IVR (%/UI/kg) 1.9 ± 0.3 1.9 ± 0.4 2.5 ± 0.4
Clearance (ml/h/kg) 5.4 ± 2.4 4.3 ± 1,2 3.0 ± 1.2

Values reported are mean ± SD.