Safety-in-use studies assess the potential for a product to elicit adverse reactions under normal use conditions. These tests are highly effective in helping determine safety and assessing consumer perception.
All safety-in-use (SIU) studies follow a common design theme. The test product is distributed to a panel of qualified volunteers who use the product at home as directed. Volunteers are evaluated by a board-certified physician at the first visit before using the test product and also at each scheduled visit during the course of the study. During the course of the study, participants record comments and opinions about the product in a daily diary, giving particular attention to safety issues, such as stinging, burning, itching, breakout, etc.
All SIU studies are distinguished by the demographics (age, gender, ethnicity, etc.) of the study populations and the medical specialty of the physician, under whose supervision the study is conducted.