A randomized pharmacokinetic study of generic tacrolimus versus reference tacrolimus in kidney transplant recipients.
Bottom Line: The ratios of geometric means were 1.02 (90% CI 97-108%, p = 0.486) for AUC(0-12h) and 1.09 (90% CI 101-118%, p = 0.057) for C(max) .Mean (SD) C(0) was 7.3(1.8) ng/mL for generic tacrolimus versus 7.0(2.1) ng/mL for reference tacrolimus based on data from days 14 and 28.Correlations between 12 h trough levels and AUC were r = 0.917 for generic tacrolimus and r = 0.887 for reference drug at day 28.
Affiliation: Division of Nephrology, Section of Transplantation, University of Cincinnati, Cincinnati, OH, USA. firstname.lastname@example.orgShow MeSH
Related in: MedlinePlus
Mentions: Correlations (r values) between C12 and AUC0–12h were 0.837 and 0.917 for generic tacrolimus at days 14 and 28, respectively, compared to 0.773 and 0.887 for reference tacrolimus (Figure 4).
Affiliation: Division of Nephrology, Section of Transplantation, University of Cincinnati, Cincinnati, OH, USA. email@example.com