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., ...Daha Fazla

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

Yayın Türü: Makale / Tam Makale
Cilt numarası: 153
Basım Tarihi: 2020
Doi Numarası: 10.1016/j.ejps.2020.105485
Dergi Adı: EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
Derginin Tarandığı İndeksler: 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 Üniversitesi Adresli: Evet

Özet

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.