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Jeanne M. Lusher, MD

JAMA. 1985;254(6):802-803.

	Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings.

The article by Rock et al¹ in this issue of THE JOURNAL calls attention to the problems of verifying the labeled potency of factor VIII concentrates. Rock et al report finding (in 1982) a considerable discrepancy between their measurements and the manufacturers-labeled factor VIII content, with the authors' assays showing overall levels of approximately 60% of the labeled values with each of four lots of one manufacturer's product. They point out the potential serious implications of such less-than labeled factor VIII content, including inadequate treatment of bleeding episodes with poor clinical response and increased factor VIII usage (at additional cost) if clinicians doubt that the bottle contains as much as stated on the label.

This issue is not a new one and no doubt reflects several problems that have been of great concern to the manufacturers of clotting factor concentrates, the US Office of Biologics (OOB) and its British . . . [Full Text PDF of this Article]

Author Affiliations
Children's Hospital of Michigan Wayne State University School of Medicine Detroit

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