Andreas Bye

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As indirect measures of rate of drug absorption (metrics), maximum plasma concentration (Cmax) is confounded by extent of drug absorption and the time to reach Cmax (tmax) is a discrete variable, dependent on blood sampling frequency. Building on the work of Endrenyi et al., we have compared different metrics, including Cmax/area under the curve of(More)
The performance of different partial AUCs, including partial AUC from zero to t(max) of the reference formulation (AUC(r)) and partial AUC from zero to tmax of test or reference formulation, whichever occurs earliest (AUC(e), as indirect measures of rate of absorption have been evaluated using simulated experiments. The performance of these metrics relative(More)
We investigated the hypothesis that distributions of continuous pharmacokinetic variables are positively skewed in nature and that logarithmic transformation of these variables restores normality. The distributions of common continuous noncompartmental pharmacokinetic variables were investigated for four different Glaxo Wellcome compounds, administered by(More)
Computer-assisted drug development (CADD) is an emerging technology for accelerating drug development based on the integration of mathematical modelling and simulation. This methodology provides a knowledge-based decisional tool on alternative development strategies based on the evaluation of potential risks on drug safety, and the definition of(More)
PURPOSE A population pharmacokinetic-pharmacodynamic model accounting for placebo effect was used to relate nicotine concentration and enforced smoking cessation craving score measured by the Tiffany rating scale short form. METHODS Twenty-four smokers were enrolled in a placebo-controlled, randomized, double-blind, three periods, crossover trial. The(More)
1. The interaction of ranitidine hydrochloride (150 mg twice daily for 15 doses) with single doses (0.15, 0.3 and 0.6 g kg-1) of ethanol was investigated in a placebo controlled study in 24 male subjects. Ethanol was given 1 h after a standard breakfast to maximise a drug ethanol effect if there is one. A balanced incomplete block design was used in that(More)
The US Human Reliability Analysis (HRA) Empirical Study (referred to as the US Study in the article) was conducted to confirm and expand on the insights developed from the International HRA Empirical Study (referred to as the International Study). Similar to the International Study, the US Study evaluated the performance of different HRA methods by(More)
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