Optimum blood sampling time windows for parameter estimation in population pharmacokinetic experiments

Gordon Graham, Leon Aarons

    Research output: Contribution to journalArticlepeer-review

    Abstract

    Clinical trials requiring the collection of pharmacokinetic information often specify blood samples to be taken at fixed times. This may be feasible when trial participants are in a controlled environment such as in early phase clinical trials, however it becomes problematic in trials where patients are in an out-patient clinic setting such as in late phase drug development. In such a situation it is common to take blood samples when it is convenient for all involved and may result in data that are uninformative. This paper proposes an approach to pharmacokinetic study design that allows greater flexibility as to when blood samples can be taken and still result in data that allows satisfactory parameter estimation. The sampling window approach proposed in this paper is based on determining time intervals around the D-optimum pharmacokinetic sampling times. These intervals are determined by allowing the sampling window design to result in a specified level of efficiency when compared to the fixed times D-optimum design. Several approaches are suggested for dealing with this design problem. Copyright © 2006 John Wiley & Sons, Ltd.
    Original languageEnglish
    Pages (from-to)4004-4019
    Number of pages15
    JournalStatistics in medicine
    Volume25
    Issue number23
    DOIs
    Publication statusPublished - 15 Dec 2006

    Keywords

    • D-optimality
    • Efficiency
    • Mixed effects models
    • Optimum experimental design
    • Pharmacokinetics
    • Sampling windows

    Fingerprint

    Dive into the research topics of 'Optimum blood sampling time windows for parameter estimation in population pharmacokinetic experiments'. Together they form a unique fingerprint.

    Cite this