An Oral Contraceptive Drug Interaction Study

Abstract

This article focuses on a two treatment, two period, two treatment sequence crossover drug interaction study of a new drug and a standard oral contraceptive therapy. Both normal theory and distribution-free statistical analyses are provided along with a notable amount of graphical insight into the dataset. For one of the variables, the decision on the presence or absence of a drug interaction is reversed depending on whether the normal theory or the distribution-free analysis is favored. The data also contain statistically significant period effects, statistically significant but clinically unimportant treatment effects, some modest degree of structural nonnormality; and modest to more extreme outliers. This and 28 other pedagogically useful datasets can be found at www.math.iup.edu/∼tshort/Bradstreet.

Supplemental data for this article can be accessed on the publisher's website.

• Bioequivalence
• Crossover
• Graphics
• Phase I Clinical Trial

Acknowledgements

The authors would like to thank the referees and the associate editor for their comments, Ms. Laurie Rittle for her careful typing of this article, and Ms. Cindy White for producing the graphics.