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A randomized pharmacokinetic study of generic tacrolimus versus reference tacrolimus in kidney transplant recipients.

Alloway RR, Sadaka B, Trofe-Clark J, Wiland A, Bloom RD - Am. J. Transplant. (2012)

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.

View Article: PubMed Central - PubMed

Affiliation: Division of Nephrology, Section of Transplantation, University of Cincinnati, Cincinnati, OH, USA. allowarr@ucmail.uc.edu

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Scatter plots of AUC0–12h versus trough concentration (C12) at (a) Day 14 (b) Day 28
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fig04: Scatter plots of AUC0–12h versus trough concentration (C12) at (a) Day 14 (b) Day 28

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).


A randomized pharmacokinetic study of generic tacrolimus versus reference tacrolimus in kidney transplant recipients.

Alloway RR, Sadaka B, Trofe-Clark J, Wiland A, Bloom RD - Am. J. Transplant. (2012)

Scatter plots of AUC0–12h versus trough concentration (C12) at (a) Day 14 (b) Day 28
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3472020&req=5

fig04: Scatter plots of AUC0–12h versus trough concentration (C12) at (a) Day 14 (b) Day 28
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).

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.

View Article: PubMed Central - PubMed

Affiliation: Division of Nephrology, Section of Transplantation, University of Cincinnati, Cincinnati, OH, USA. allowarr@ucmail.uc.edu

Show MeSH
Related in: MedlinePlus