Non-Compartment and compartmental pharmacokinetics, efficacy, and safety of Kedrion FIX concentrate

Castaman, G.; Borchiellini, A.; Santagostino, E.; Radossi, P.; Aksu, S.; Yilmaz, M.; Serban, M.; Uscatescu, V; Truica, C.; Fasulo, M.; Mancuso, M.; Paladino, E.; Valpreda, A.; Guarnieri, C.; Macchia, R.; Scarpellini, M.; Mathew, P.; Morfini, M.

doi:10.1016/j.ejps.2020.105485

Non-Compartment and compartmental pharmacokinetics, efficacy, and safety of Kedrion FIX concentrate

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Castaman G., Borchiellini A., Santagostino E., Radossi P., Aksu S., Yilmaz M., ...More

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, vol.153, 2020 (Journal Indexed in SCI)

Publication Type: Article / Article
Volume: 153
Publication Date: 2020
Doi Number: 10.1016/j.ejps.2020.105485
Title of Journal : EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Abstract

Background: An open-label phase II, multicenter clinical trial was conducted at 11 Haemophilia Centres in Italy, Romania, and Turkey, to evaluate the pharmacokinetics (PK), efficacy, and safety of high purity, plasma-derived, double virus inactivated and double nano-filtered factor IX (pd-FIX) concentrate (Kedrion FIX), EudraCT Number: 2005-006186-14.