1. The Statistical Evaluation of a Three-Period Two-Treatment Crossover Pharmacokinetic Drug Interaction Study
- Author
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J L Ciminera, M H Gregg, and J A Bolognese
- Subjects
Statistics and Probability ,Drug ,Absorption (pharmacology) ,General Immunology and Microbiology ,Applied Mathematics ,media_common.quotation_subject ,Crossover ,General Medicine ,Drug interaction ,Pharmacology ,General Biochemistry, Genetics and Molecular Biology ,Toxicology ,Pharmacokinetics ,Distribution (pharmacology) ,General Agricultural and Biological Sciences ,Mathematics ,media_common - 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.
- Published
- 1987
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