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Area Under the Curve Bioequivalence of Mycophenolate Mofetil: CellCept® vs Generic

1 November 2010


Therapeutic drug monitoring (TDM) of mycophenolate mofetil (MMF) has been investigated using multiple linear regression (MLR) and bayesian pharmacokinetics (BAY) independently. Some studies have shown that therapeutic drug monitoring (TDM) of MMF via measuring area under the curve (AUC) may decrease risk of rejection as well as toxicity. Between May 2008 and June 2009, the FDA granted approval to 7 different manufacturers of generic MMF. Secondary to the between-patient and within-patient variability of MMF pharmacokinetics, it is important to use validated MLR and BAY models. These models have thus far been designed using only CellCept®. In this study, MLR and BAY models are used to evaluate the bioequivalence of mycophenolic acid (MPA) AUC of CellCept® (innovator MMF) compared to generic MMF (manufactured by Mylan) in renal transplant (RT) recipients. Four of 6 patients had generic MMF AUC levels within 90% - 110% AUC of innovator, and 5 of 6 patients had levels within 80 - 125%. Current MLR and BAY models might not be applicable to patients taking generic MMF.


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