Therapeutic equivalence and pharmacokinetics of generic tacrolimus formulation in de novo kidney transplant patients.

@article{Min2013TherapeuticEA,
  title={Therapeutic equivalence and pharmacokinetics of generic tacrolimus formulation in de novo kidney transplant patients.},
  author={Sang Il Min and Jongwon Ha and Yon Su Kim and Sang Hyun Ahn and Taejin Park and Dae Do Park and Suh Min Kim and Seung-Kee Min and Hyejin Hong and Curie Ahn and S J Kim},
  journal={Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association},
  year={2013},
  volume={28 12},
  pages={3110-9}
}
BACKGROUND There is a growing concern about the therapeutic equivalence of the generic tacrolimus formulation (GEN Tacrolimus) to the reference tacrolimus (REF Tacrolimus) in solid organ transplantation. METHODS A prospective, randomized study of 126 de novo renal transplant patients was conducted to compare the efficacy, safety and pharmacokinetic (PK) profiles between GEN tacrolimus (n = 63) and REF tacrolimus (n = 63). The PK of tacrolimus was evaluated on Day 10 and 6 months under steady… CONTINUE READING
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