Preclinical pharmacokinetics and biodistribution of subcutaneously administered glycoPEGylated recombinant factor VIII (N8-GP) and development of a human pharmacokinetic prediction model.

Rode, F; Almholt, K; Petersen, M; Kreilgaard, M; Kjalke, M; Karpf, D M; Groth, A V; Johansen, P B; Larsen, L F; Loftager, M; Haaning, J

Preclinical pharmacokinetics and biodistribution of subcutaneously administered glycoPEGylated recombinant factor VIII (N8-GP) and development of a human pharmacokinetic prediction model.

Rode, F; Almholt, K; Petersen, M; Kreilgaard, M; Kjalke, M; Karpf, D M; Groth, A V; Johansen, P B; Larsen, L F; Loftager, M; Haaning, J.

Affiliation

Rode F; Global Research, Novo Nordisk A/S, Måløv, Denmark.
Almholt K; Global Research, Novo Nordisk A/S, Måløv, Denmark.
Petersen M; Global Research, Novo Nordisk A/S, Måløv, Denmark.
Kreilgaard M; Global Research, Novo Nordisk A/S, Måløv, Denmark.
Kjalke M; Global Research, Novo Nordisk A/S, Måløv, Denmark.
Karpf DM; Global Research, Novo Nordisk A/S, Måløv, Denmark.
Groth AV; Global Development, Novo Nordisk A/S, Søborg, Denmark.
Johansen PB; Global Research, Novo Nordisk A/S, Måløv, Denmark.
Larsen LF; Global Research, Novo Nordisk A/S, Måløv, Denmark.
Loftager M; Global Research, Novo Nordisk A/S, Måløv, Denmark.
Haaning J; Global Development, Novo Nordisk A/S, Søborg, Denmark.

J Thromb Haemost ; 16(6): 1141-1152, 2018 06.

Article in En | MEDLINE | ID: mdl-29582559

Subject(s)

Factor VIII/administration & dosage; Factor VIII/pharmacokinetics; Hemophilia A/drug therapy; Hemostatics/administration & dosage; Hemostatics/pharmacokinetics; Models, Biological; Polyethylene Glycols/administration & dosage; Polyethylene Glycols/pharmacokinetics; Animals; Disease Models, Animal; Factor VIII/genetics; Factor VIII/metabolism; Half-Life; Hemophilia A/blood; Hemophilia A/genetics; Hemostatics/blood; Humans; Injections, Intravenous; Injections, Subcutaneous; Macaca fascicularis; Mice, Knockout; Skin Absorption; Species Specificity; Tissue Distribution

Key words

factor VIII; hemophilia A; immunohistochemistry; pharmacokinetics; subcutaneous injections

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Polyethylene Glycols / Factor VIII / Hemostatics / Hemophilia A / Models, Biological Type of study: Prognostic_studies / Risk_factors_studies Limits: Animals / Humans Language: En Journal: J Thromb Haemost Journal subject: HEMATOLOGIA Year: 2018 Document type: Article Affiliation country: Denmark Country of publication: United kingdom

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