Bioequivalence comparison of Sandimmune and Neoral versus Sang- 35 cyclosporine in kidney transplant recipients
ASN 30th Annual Meeting, San Antonio
J Am Soc Nephrol (Sep) 8:672A 1997
Sang-35, Sandimmune(r), and Neoral(r) are three preparations of cyclosporine. Sang-35 is under review by the United States Food and Drug Administration. Alloway and colleagues showed that Sang-35 is bioequivalent to Neoral(r), but has a 63% higher maximum concentration, a 58% shorter time to maximum concentration and and a 27% larger area under the plasma concentration:time curve than Sandimmune(r).
Comment: This study shows the pharmacokinetic differences among three cyclosporine preparations and illustrates the techniques for establishing bioequivalence among different preparations of the same drug. Sang-35 should be compared to Neoral(r) rather than Sandimmune(r). (George R. Aronoff, M.D., University of Louisville, Kentucky)
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ASN 30th Annual Meeting, San Antonio
ARF etiology : Cyclosporine, ARF in transplant patients
Transplant : Transplantation