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New study investigates inter-individual variability in predicted phenytoin clearance using Simcyp
Date: 04 Sep 2009
A new paper published in the European Journal of Clinical Pharmacology demonstrates the use of in vitro kinetic data to predict in vivo clearance. The study was undertaken by researchers at Flinders University, Adelaide, in conjunction with Simcyp and the University of Sheffield.
The group used in vitro kinetic data, generated in the presence and absence of albumin, to predict phenytoin clearance. The results were then compared to clinical data. The simulations were most accurate when based on ‘albumin adjusted’ data, highlighting the importance of careful consideration of in vitro experimental design. Furthermore, the predictions identified inter-individual variability outside the reported range of pharmacokinetic studies in healthy volunteers.
The authors conclude that mechanistic modelling and simulation allows inter-individual variability to be considered and that this approach may offer a superior indication of covariates in the clinic than that provided by small pharmacokinetic studies.
The paper, by Polasek et al., is available as an e-pub ahead of print. Please link to PubMed for the abstract and full text options.