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| Number of infusion sets | Total = 107 Published = 101 Unpublished = 6 |
Total = 7 Published = 7 Unpublished = 0 |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) |