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Recombinant proteins / Haemophilia / Drug discovery / Pharmaceutical industry / Von Willebrand disease / Factor VIII / Moroctocog alfa / Coagulation / Factor VII / Blood / Coagulation system / Biology


Pharmacology Toxicology Memo, May 31, [removed]Novoeight
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Company

Perioperative / BP / CVS / Background Novo Nordisk Inc. / Novo Nordisk Inc. / /

Country

United States / /

Event

FDA Phase / Product Issues / /

IndustryTerm

serum-free media / container closure systems / carrier protein / similar products / treatment site / manufacturing / marketed products / /

MedicalCondition

local irritation / Hemophilia A / joint bleeding model hemophilia A / severe hemophilia / Carcinogenesis / hemophilia A. The / injury / hemophilia A. Deletion / hypersensitivity / hemophilic synovitis / hemophilia / dissociation / /

Organization

office of Blood Research / United States Food and Drug Administration Center for Biologics Evaluation and Research Pharmacology / FDA / Division of Hematology / Department of Health and Human Services / /

Person

Nissa A. Brown / Anne M. Pilaro / Maximum / Comment / Basil Golding / /

Position

Doses General / Pharmacologist / treating physician / producer / Non-clinical Pharmacology/Toxicology General / Director Division / Supervisory Toxicologist / /

Product

Sodium Chloride / NovoEight / FVIII / S6 / NovoEight® / dogs / mice / Telm070501 / /

Technology

pharmacokinetics / antibodies / Pharmacodynamics / gel electrophoresis / be characterized using the anti-FVIII monoclonal antibodies / /

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