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.
MontgomeryDC. Design and Analysis of Experiments. 2nd ed.New York: Wiley; 1984.
3.
JuliousS. Designing clinical trials with uncertain estimates of variability. Pharm Stat. 2004;3:261–268.
4.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, E1. The extent of population exposure to assess clinical safety for drugs intended for long-term treatment of non-life-threatening condition. Federal Register, vol. 60, March 1, 1995, p. 11270.
5.
HoggRVCraigAT. Introduction to Mathematical Statistics. 3rd ed.New York: Macmillan; 1970.
