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Optimal experimental designs for dose–response studies with continuous endpoints

Content Provider	PubMed Central
Author	Tim, Holland-letz Annette, Kopp-schneider
Abstract	In most areas of clinical and preclinical research, the required sample size determines the costs and effort for any project, and thus, optimizing sample size is of primary importance. An experimental design of dose–response studies is determined by the number and choice of dose levels as well as the allocation of sample size to each level. The experimental design of toxicological studies tends to be motivated by convention. Statistical optimal design theory, however, allows the setting of experimental conditions (dose levels, measurement times, etc.) in a way which minimizes the number of required measurements and subjects to obtain the desired precision of the results. While the general theory is well established, the mathematical complexity of the problem so far prevents widespread use of these techniques in practical studies. The paper explains the concepts of statistical optimal design theory with a minimum of mathematical terminology and uses these concepts to generate concrete usable D-optimal experimental designs for dose–response studies on the basis of three common dose–response functions in toxicology: log-logistic, log-normal and Weibull functions with four parameters each. The resulting designs usually require control plus only three dose levels and are quite intuitively plausible. The optimal designs are compared to traditional designs such as the typical setup of cytotoxicity studies for 96-well plates. As the optimal design depends on prior estimates of the dose–response function parameters, it is shown what loss of efficiency occurs if the parameters for design determination are misspecified, and how Bayes optimal designs can improve the situation.
Related Links	http://dx.doi.org/10.1007/s00204-014-1335-2
Ending Page	2068
Page Count	10
Starting Page	2059
File Format	PDF
ISSN	03405761
e-ISSN	14320738
Journal	Archives of Toxicology
Issue Number	11
Volume Number	89
Language	English
Publisher	Springer Berlin Heidelberg
Publisher Date	2015-11-01
Access Restriction	Open
Rights Holder	Springer Berlin Heidelberg
Subject Keyword	Toxicology Health, Toxicology and Mutagenesis Research in Higher Education
Content Type	Text
Resource Type	Article
Subject	Health, Toxicology and Mutagenesis Medicine Toxicology

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