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J. Thromb. Haemost. · Jun 2018
Comparative StudyPreclinical pharmacokinetics and biodistribution of subcutaneously administered glycoPEGylated recombinant factor VIII (N8-GP) and development of a human pharmacokinetic prediction model.
- F Rode, K Almholt, M Petersen, M Kreilgaard, M Kjalke, D M Karpf, A V Groth, P B Johansen, L F Larsen, M Loftager, and J Haaning.
- Global Research, Novo Nordisk A/S, Måløv, Denmark.
- J. Thromb. Haemost. 2018 Jun 1; 16 (6): 1141-1152.
AbstractEssentials N8-GP is an extended half-life recombinant factor VIII (FVIII) for the treatment of hemophilia A. Subcutaneous (SC) FVIII dosing might reduce the treatment burden of prophylaxis. SC N8-GP has a favorable PK profile in animal models and disappears from skin injection sites. Combined animal (SC) and clinical (IV) data suggest that daily SC dosing may provide prophylaxis.© 2018 Novo Nordisk A/S. Journal of Thombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society of Thombosis and Haemostasis.
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