Statistical considerations for some studies of over-the-counter drugs

In this article, the label comprehension and actual use studies that may be required for an over-the-counter new drug regulatory submission are introduced. Design for these studies and statistical issues are described. Because confidence interval is a tool that plays a central role in these studies, information needed and appropriate sample size estimation approaches are discussed. Carefully designed and analyzed studies would enhance their success rate and provide more useful information from the studies.