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The Statistical Evaluation of a Three-Period Two-Treatment Crossover Pharmacokinetic Drug Interaction Study

J. L. Ciminera, J. A. Bolognese and M. H. Gregg
Biometrics
Vol. 43, No. 3 (Sep., 1987), pp. 713-718
DOI: 10.2307/2532008
Stable URL: http://www.jstor.org/stable/2532008
Page Count: 6
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The Statistical Evaluation of a Three-Period Two-Treatment Crossover Pharmacokinetic Drug Interaction Study
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Abstract

In a pharmacokinetic drug interaction study, the purpose is to determine whether the coadministration of a drug A with a second drug B alters the absorption/distribution/metabolism/elimination profile of either drug. While the usual design for such studies is a three-period crossover, it cannot be analyzed as such, because the plasma-level data of drug B will be 0 when drug A is given alone, and vice versa. The easiest way to proceed is to do two sets of paired analyses, one on the absorption profile of A (A vs AB), and the other on the absorption profile of B (B vs AB). A complete separation of the total sources of variation and degrees of freedom is presented along with a numerical example.

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