An ultrapure plasma-derived monoclonal antibody-purified factor IX concentrate (Nonafact®), results of phase III and IV clinical studies

Author:

MAUSER-BUNSCHOTEN E. P.,KLEINE BUDDE I.,LOPACIUK S.,KOOPMAN M. M. W.,Van Der MEER F. J. M.,NOVÀKOVÀ I. R. O.,YPMA P.,Van Der LINDEN P. W. G.,WINDYGA J.,STRENGERS P. F. W.

Publisher

Wiley

Subject

Genetics(clinical),Hematology,General Medicine

Reference20 articles.

1. Measurement of activated factor IX in factor IX concentrates: correlation with in vivo thrombogenicity;Gray;Thromb Haemost,1995

2. Studies on the removal of abnormal prion protein by processes used in the manufacture of human plasma products;Foster;Vox Sang,2000

3. Factor VIII and transmissible spongiform encephalopathy: the case for safety;Cervenakova;Haemophilia,2002

4. Scrapie removal using Planova virus removal filters;Tateishi;Biologicals,2001

5. The European Agency for the Evaluation of Medicinal Products CPMP 198/95, Final: ‘Note for guidance to assess efficacy and safety of human plasma derived Factor VIII:C and Factor IX:C products in clinical trials in haemophiliacs before and after authorisation’ 1996

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