Article
Bottom-up modeling and simulation of tacrolimus clearance: prospective investigation of blood cell distribution, sex and CYP3A5 expression as covariates and assessment of study power.
Biopharmaceutics & drug disposition - 1 Dec 2011
Ohtani Hisakazu, Barter Zoe, Minematsu Tsuyoshi, Makuuchi Masatoshi, Sawada Yasufumi, Rostami-Hodjegan Amin
Abstract excerpt
The objectives were to investigate the ability of population-based in vitro-in vivo extrapolation (IVIVE) to reproduce the influence of haematocrit on the clearance of tacrolimus, observed previously, and to assess the power of clinical studies to detect the effects of covariates on the clearance of tacrolimus. A population-based pharmacokinetic simulator (Simcyp) was used to simulate tacrolimus clearance from in...
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