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Safety of Human Albumin as a Constituent of Biologic Therapeutic Products by D.B.L. McClelland is a Medicine article available to read on EtoBox.

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his review reexamines the evidence for the virologic safety of human albumin products. This is important because HA is used in products such T as recombinant coagulation factors (factorVIII), recombinant hematopoietic factors recombinant human granulocyte-monocyte-colony-stimulating factor and erythropoietin), interferons (interferon a-2b, interferon p-1 b), streptokinase, and some vaccines. Inappropriate emphasis on the theoretical risks of transmitting infectious agents could lead to public and professional concerns. Reluctance to prescribe or receive products that contain HA may deprive patients of effective treatment or compromise important immunization programs. All the studies examining infectivity and virus inactivation in albumin products relate to the large doses of albumin given as infusion solutions (typically20 gldose unit). When used as an additive in formulating other products, doses of albumin (and presumably, therefore, of any contaminating agent) are approximately three orders of magnitude less. Thus, any evidence supporting the safety of HA should provide even greater reassurance about the safety of these small doses. This review is concentrated on studies of huma

Who reads Safety of Human Albumin as a Constituent of Biologic Therapeutic Products?

Author

D.B.L. McClelland

Publisher

Elsevier Science; John Wiley and Sons; Wiley (Blackwell Publishing); Blackwell Publishing Inc.; Elsevier; Elsevier BV; Wiley (ISSN 0372-1248)

Published

1998

Language

EN

Field

Medicine (Health Sciences)