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Statistical Methods in Medical Research
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The Bayesian analysis of a pivotal pharmacokinetic study

N J Rahman

Department of Mathematics, Imperial College of Science, Technology and Medicine, London, UK

J C Wakefield

Department of Epidemiology and Public Health, Imperial College School of Medicine at St Mary's, London, UK, j.c.wakefield{at}ic.ac.uk

D A Stephens

Department of Mathematics, Imperial College of Science, Technology and Medicine, London, UK

C Falcoz

Glaxo Wellcome, Department of Clinical Pharmacokinetics, Middlesex, UK

The aim of this paper is to carry out a detailed Bayesian population pharmacokinetic analysis of a three-period cross-over study of the drug fluticasone propionate carried out in 12 healthy male volunteers. The study was carried out to characterize the pharmacokinetics of the drug, in particular to investigate dose proportionality. We examine the appropriateness of modelling assumptions via a variety of diagnostic techniques. We also examine the effect of deleting time points at which the concentration was recorded as below the limit of quantification, as opposed to including these points as censored observations. We assess dose proportionality before carrying out a final combined analysis of data from all three doses.

Statistical Methods in Medical Research, Vol. 8, No. 3, 195-216 (1999)
DOI: 10.1177/096228029900800303
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