A new population pharmacokinetic model for recombinant factor IX-Fc fusion concentrate including young children with haemophilia B.
Sjoerd F KoopmanTine M H J GoedhartLaura H BukkemsTrevor M MuldersFrank W G LeebeekKarin FijnvandraatMichiel CoppensMary MathiasPeter W CollinsR Campbell TaitCatherine N BagotNicola CurryJeanette PaynePratima ChowdaryMarjon H CnossenRon A A Mathôtnull nullPublished in: British journal of clinical pharmacology (2023)
The published population PK model significantly underpredicted FIX activity levels. The new model better describes rFIX-Fc PK, especially for children <12 years of age. This study underlines the necessity to strive for representative population PK models, thereby avoiding extrapolation outside the studied population.