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. Author manuscript; available in PMC: 2014 Jul 1.
Published in final edited form as: J Pharm Sci. 2013 Apr 25;102(7):2380–2394. doi: 10.1002/jps.23566

Table 1.

Summary of FVIII PK studies.

Hemophilia Models Normal Models
Year range 1985–2012 1996–2012
Number of infusion sets Total = 107
Published = 101
Unpublished = 6
Total = 7
Published = 7
Unpublished = 0
Number of publications 58 5
FVIII formulation BDD rFVIII = 23
Cryoprecipitate = 2
Full length rFVIII = 39
Plasma derived = 40
Mixture = 3
BDD rFVIII = 2
Full length rFVIII = 5
Assay type APTT = 55
Chromogenic = 35
Both = 5
Unspecified = 12
APTT = 0
Chromogenic = 5
ELISA = 2
Species Human = 80
Dog = 8
Mouse = 19
Monkey = 2
Rabbit = 1
Rat = 1
Mice = 3
Dose range IU/kg (median) Human: [15,100] (50)
Dog: [50,500] (125)
Mouse: [10,400] (125)
Monkey: [100,317] (n=2)
Rabbit: 100
Rat: 400
Mice: [125,400] (222)