NDLI: Sample size/power calculations for repeated ordinal measurements in population pharmacodynamic experiments

Content Provider	Springer Nature Link
Author	Ogungbenro, Kayode Aarons, Leon
Copyright Year	2009
Abstract	Population pharmacodynamic experiments sometime involve repeated measurements of ordinal random variables at specific time points. Such longitudinal data presents a challenge during modelling due to correlation between measurements within an individual and often mixed-effects modelling approach may be used for the analysis. It is important that these studies are adequately powered by including an adequate number of subjects in order to detect a significant treatment effect. This paper describes a method for calculating sample size for repeated ordinal measurements in population pharmacodynamic experiments based on analysis by a mixed-effects modelling approach. The Wald test is used for testing the significance of treatment effects. This method is fast, simple and efficient. It can also be extended to account for differential allocation of subjects to the groups and unbalanced sampling designs between and within groups. The results obtained from two simulation studies using nonlinear mixed-effects modelling software (NONMEM) showed good agreement between the power obtained from simulation and nominal power used for sample size calculations.
Starting Page	67
Ending Page	83
Page Count	17
File Format	PDF
ISSN	1567567X
Journal	Journal of Pharmacokinetics and Pharmacodynamics
Volume Number	37
Issue Number	1
e-ISSN	15738744
Language	English
Publisher	Springer US
Publisher Date	2009-12-05
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Ordinal measurements Sample size Power Ordered categorical Cumulative logit Population pharmacodynamics Mixed-effects modelling Clinical trials Biochemistry Biomedical Engineering Veterinary Medicine Pharmacy Pharmacology/Toxicology
Content Type	Text
Resource Type	Article
Subject	Pharmacology

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