Some considerations on the design of population pharmacokinetic studies

Duffull, Stephen, Waterhouse, Tim and Eccleston, John (2005) Some considerations on the design of population pharmacokinetic studies. Journal of Pharmacokinetics and Pharmacodynamics, 32 3-4: 441-457. doi:10.1007/s10928-005-0034-2

Author Duffull, Stephen
Waterhouse, Tim
Eccleston, John
Title Some considerations on the design of population pharmacokinetic studies
Journal name Journal of Pharmacokinetics and Pharmacodynamics   Check publisher's open access policy
ISSN 1567-567X
Publication date 2005-01-01
Sub-type Article (original research)
DOI 10.1007/s10928-005-0034-2
Open Access Status Not yet assessed
Volume 32
Issue 3-4
Start page 441
End page 457
Total pages 17
Place of publication New York, United States
Publisher Kluwer Academic/Plenum
Language eng
Subject C1
320599 Pharmacology not elsewhere classified
730399 Health and support services not elsewhere classified
Abstract The goal of this manuscript is to introduce a framework for consideration of designs for population pharmacokinetic orpharmacokinetic-pharmacodynamic studies. A standard one compartment pharmacokinetic model with first-order input and elimination is considered. A series of theoretical designs are considered that explore the influence of optimizing the allocation of sampling times, allocating patients to elementary designs, consideration of sparse sampling and unbalanced designs and also the influence of single vs. multiple dose designs. It was found that what appears to be relatively sparse sampling (less blood samples per patient than the number of fixed effects parameters to estimate) can also be highly informative. Overall, it is evident that exploring the population design space can yield many parsimonious designs that are efficient for parameter estimation and that may not otherwise have been considered without the aid of optimal design theory.
Keyword Population pharmacokinetics
D-optimal Design
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

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Created: Wed, 15 Aug 2007, 16:43:12 EST