Article
Population pharmacokinetic modeling for dose setting of nonacog beta pegol (N9-GP), a glycoPEGylated recombinant factor IX.
Journal of thrombosis and haemostasis : JTH - 1 Nov 2012
Collins P W, Møss J, Knobe K, Groth A, Colberg T, Watson E
Abstract excerpt
BACKGROUND: nonacog beta pegol (N9-GP) is a glycoPEGylated recombinant factor IX (rFIX) molecule with a prolonged half-life. OBJECTIVES: To provide information on potential dose regimens for N9-GP for phase 3 pivotal and surgery trials. METHODS: A population pharmacokinetic model was developed from single-dose data derived from the first human-dose trial with N9-GP in hemophilia B patients, and was used to...
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