Pharmacokinetics of a new human plasma‐derived double virus inactivated and nanofiltered factor IX concentrate in previously treated severe or moderately severe haemophilia B patients

Author:

Castaman Giancarlo1,Borchiellini Alessandra2,Santagostino Elena3,Tagariello Giuseppe4ORCID,Serban Margit5,Uscatescu Marusia6,Truica Cristina7,Farrugia Albert8ORCID,Morfini Massimo9ORCID

Affiliation:

1. AOU Careggi Malattie Emorragiche e della Coagulazione Firenze Italy

2. Department of Haematology S. Giovanni Battista Hospital Turin Italy

3. Angelo Bianchi Bonomi Hemophilia and Thrombosis Centre, Istituto di Ricovero e Cura a Carattere Scientifico Cà Granda Foundation Maggiore Hospital Policlinico Milan Italy

4. Department of Haematology Haemophilia Centre Castelfranco Veneto Italy

5. Louis Turcanu' Louis Turcanu” Children Clinical Emergency Hospital Timisoara Romania

6. Fundeni Clinical Institute Bucharest Romania

7. Hematology Department Country Emergency Hospital Baia Mare Romania

8. Surgery (QEII Medical Centre) The University of Western Australia (M509) Crawley WA Australia

9. Italian Association of Haemophilia Centres Milan Italy

Publisher

Wiley

Subject

Genetics(clinical),Hematology,General Medicine

Reference10 articles.

1. Neoantigens and antibodies to factor VIII

2. Committee for Proprietary Medicinal Products (Cpmp).Guideline on plasma‐derived medicinal products. July 21 2011 pag.11/33.https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-plasma-derived-medicinal-products_en.pdf. Accessed on May 29 2019.

3. The Design and Analysis of Half-Life and Recovery Studies for Factor VIII and Factor IX

4. LeeM MorfiniM SchulmanS Ingerslev J the Factor VIII/Factor IX Scientific and Standardization Committee of the International Society for Thrombosis and Haemostasis.Scientific and standardization committee communication: the design and analysis of pharmacokinetic studies of coagulation factors. ISTH Web site. Accessed March 21 2001:1‐9.

5. In vivo recovery of factor VIII following transfusion: a survey of recent data and publications to assess the influence of standards used for potency assignment. On behalf of the Subcommittee on Factor VIII and IX of the Scientific and Standardization Committee of the ISTH;Prowse CV;Thromb Haemost,1995

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