Comparing sampling methods for pharmacokinetic studies using model averaged derived parameters. (8th August 2017)

• Record Type: Journal Article
• Authors: Barnett, Helen Yvette; Geys, Helena; Jacobs, Tom; Jaki, Thomas
• Is Part Of: Statistics in medicine. Volume 36:Number 27(2017)
• Page Start: 4301
• Page End: 4315
• Publication Date: 2017-08-08
• Subjects: comparing sampling methods -- derived parameters -- equivalence testing -- multiple comparison -- pharmacokinetic studies -- simultaneous inference; Medical statistics -- Periodicals; Statistique médicale -- Périodiques; Statistiques médicales -- Périodiques; 610.727
• DOI: 10.1002/sim.7436
• Languages: English
• ISSNs: 0277-6715

Abstract

Abstract : Pharmacokinetic studies aim to study how a compound is absorbed, distributed, metabolised, and excreted. The concentration of the compound in the blood or plasma is measured at different time points after administration and pharmacokinetic parameters such as the area under the curve ( A U C ) or maximum concentration ( C m a x ) are derived from the resulting concentration time profile. In this paper, we want to compare different methods for collecting concentration measurements (traditional sampling versus microsampling) on the basis of these derived parameters. We adjust and evaluate an existing method for testing superiority of multiple derived parameters that accounts for model uncertainty. We subsequently extend the approach to allow testing for equivalence. We motivate the methods through an illustrative example and evaluate the performance using simulations. The extensions show promising results for application to the desired setting.