Preclinical studies of recombinant factor IX.
Semin Hematol
; 35(2 Suppl 2): 28-32, 1998 Apr.
Article
en En
| MEDLINE
| ID: mdl-9565164
ABSTRACT
Recombinant factor IX (rFIX) has been extensively evaluated in preclinical studies. Dog model study of hemophilia B indicated that rFIX was as effective as a highly purified plasma-derived replacement factor in normalizing indices of hemostasis. Pharmacokinetic studies indicated a dose-proportional profile for rFIX. Pharmacokinetic/pharmacodynamic analysis showed that increases in the plasma concentration of rFIX following administration were closely correlated with measured factor IX activity in the plasma. Appropriate in vitro and in vivo toxicology studies have been performed to support the clinical use of rFIX for the treatment of hemophilia B. Finally, experiments in a model of thrombogenicity indicated that in animals rFIX has a low thrombogenic potential. The preclinical results provided a basis for proceeding with human clinical trials.
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Base de datos:
MEDLINE
Asunto principal:
Factor IX
/
Hemofilia B
Tipo de estudio:
Prognostic_studies
Límite:
Animals
/
Humans
Idioma:
En
Revista:
Semin Hematol
Año:
1998
Tipo del documento:
Article
País de afiliación:
Estados Unidos