Exploratory assessment of dose proportionality: review of current approaches and proposal for a practical criterion.
@article{Hummel2009ExploratoryAO,
title={Exploratory assessment of dose proportionality: review of current approaches and proposal for a practical criterion.},
author={J{\"u}rgen Hummel and Sue McKendrick and Charles J. Brindley and Raymond David French},
journal={Pharmaceutical statistics},
year={2009},
volume={8 1},
pages={
38-49
}
}This article reviews currently used approaches for establishing dose proportionality in Phase I dose escalation studies. A review of relevant literature between 2002 and 2006 found that the power model was the preferred choice for assessing dose proportionality in about one-third of the articles. This article promotes the use of the power model and a conceptually appealing extension, i.e. a criterion based on comparing the 90% confidence interval for the ratio of predicted mean values from the…
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