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

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

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, vol.153, 2020 (SCI-Expanded, Scopus)

Publication Type: Article / Article
Volume: 153
Publication Date: 2020
Doi Number: 10.1016/j.ejps.2020.105485
Journal Name: EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, BIOSIS, CAB Abstracts, Chemical Abstracts Core, EMBASE, International Pharmaceutical Abstracts, MEDLINE, Veterinary Science Database
Hacettepe University Affiliated: Yes

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.