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• W2116729695 abstract "Summary. Background: Deletion of the B‐domain of recombinant blood coagulation factor VIII (BDDrFVIII) increases the manufacturing yield of the product but does not impair in vitro or in vivo functionality. BDDrFVIII (ReFacto®) has been developed with the additional benefit of being formulated without human albumin. Objective: The primary objective of this three‐way crossover‐design study was to compare the pharmacokinetic (PK) parameters of two BDDrFVIII formulations (one reconstituted with 5 mL of sterile water, the other reconstituted with 4 mL sodium chloride 0.9% USP) with those of a plasma‐derived, full‐length FVIII preparation (Hemofil® M) in patients with haemophilia A to determine bioequivalence. Methods: A series of blood samples were collected over a period of 48 h after i.v. administration of each of the FVIII preparations. Plasma FVIII activity was determined using a validated chromogenic substrate assay. Plasma FVIII activity vs. time curves was characterized for a standard set of PK parameter estimates. Two parameter estimates, the maximum plasma concentration ( C max ) and the area under plasma concentration vs. time curves ( AUC s), were used to evaluate bioequivalence. The two preparations were considered bioequivalent if the 90% confidence intervals for the ratio of geometric means for C max and AUC s fell within the bioequivalence window of 80% to 125%. Results/Conclusion: Results show that each BDDrFVIII formulation is bioequivalent to Hemofil M and the two formulations of BDDrFVIII are bioequivalent to each other." @default.
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• W2116729695 date "2005-03-01" @default.
• W2116729695 modified "2023-10-15" @default.
• W2116729695 title "B-domain deleted recombinant factor VIII preparations are bioequivalent to a monoclonal antibody purified plasma-derived factor VIII concentrate: a randomized, three-way crossover study" @default.
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• W2116729695 doi "https://doi.org/10.1111/j.1365-2516.2005.01068.x" @default.
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