Factor VIII (FVIII) is indicated for the prevention or treatment of bleeding in patients with hemophilia A. FVIII product stability under high and fluctuating temperatures is important, particularly for patients who reside in, or travel to, regions with high ambient temperatures, as they may remove their product from the refrigerator and return it, unused, multiple times. We evaluated the effect of variable temperature storage conditions, including up to 40 °C, on the stability of the recombinant FVIII product, turoctocog alfa.
Napolitano, M., Nøhr, A.M. (2019). The Effect of Fluctuating Temperature on the Stability of Turoctocog Alfa for Hemophilia A. DRUGS IN R&D [10.1007/s40268-019-00290-3].
The Effect of Fluctuating Temperature on the Stability of Turoctocog Alfa for Hemophilia A
Napolitano, Mariasanta
Writing – Original Draft Preparation
;
2019-01-01
Abstract
Factor VIII (FVIII) is indicated for the prevention or treatment of bleeding in patients with hemophilia A. FVIII product stability under high and fluctuating temperatures is important, particularly for patients who reside in, or travel to, regions with high ambient temperatures, as they may remove their product from the refrigerator and return it, unused, multiple times. We evaluated the effect of variable temperature storage conditions, including up to 40 °C, on the stability of the recombinant FVIII product, turoctocog alfa.
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