Harmonization of Activity Determination Requirements for Recombinant Blood Clotting Factor rFVIIa

Resumo

The interchangeability of coagulation methods for determining the activity of recombinant blood clotting factor rFVIIa was assessed. Single-factor analysis of variance (ANOVA) and comparison of the metrological characteristics of the methods led to the conclusion that results obtained by reproducing the methods of the European Pharmacopoeia and Generium were comparable and interchangeable. One method could be used to confirm that a drug conformed to regulations established using another method. The Generium method was chosen for introduction into national pharmacopoeial practice because it was more economical.