Abstract
In a clinical phase II study the goal was to show the dose linearity and dose dependency of a test drug. Three different doses of the drug were tested in a group of patients. The study was conducted as a three period crossover experiment. The patients were randomized to the six different sequences of the test drug. The main target variables were pharmacokinetic parameters like AUC.
An appropriate statistieal model to test departures from dose linearity is introdueed. This model ineludes a sequence and aperiod effeet. A very general theory (see Roebruek 1982, 1983) to eonstruet optimal invariant F tests in mixed models is reviewed and explained in a geometrie al setup. The methods are applied to the model as defined above. First, the hypotheses are stated in apreeise way. Then the eorresponding tests statisties are presented and it is shown how to analyze the eorresponding data using SAS.
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© 1997 Springer-Verlag Berlin Heidelberg
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Heimann, G. (1997). Tests for Linearity and Tests for Zero Slope in Crossover Studies. In: Kitsos, C.P., Edler, L. (eds) Industrial Statistics. Contributions to Statistics. Physica, Heidelberg. https://doi.org/10.1007/978-3-642-59268-3_21
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DOI: https://doi.org/10.1007/978-3-642-59268-3_21
Publisher Name: Physica, Heidelberg
Print ISBN: 978-3-7908-1042-4
Online ISBN: 978-3-642-59268-3
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