This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 343
Type: Contributed
Date/Time: Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #308218
Title: Statistical Considerations for Label Comprehension Studies: A Statistical Reviewer's Perspective
Author(s): Yan Wang*+
Companies: FDA
Address: 10903 New Hampshire Avenue , Silver Spring, MD, 20993-0002,
Keywords: Over-the-counter drugs ; label comprehension studies

An over-the-counter (OTC) drug product is required to provide consumers with the information necessary for safe and effective use of the product. To develop an OTC drug product label that meets the regulatory requirement, the drug sponsor often conducts label comprehension (LC) studies to demonstrate consumer understanding of the important communication elements of the label. LC studies are generally open label and single arm studies. Historically, these studies have been primarily designed without pre-defined study goals and with all the analyses done post hoc; thus, the decision about the "success" of these studies relied on whether the label comprehension level was "good enough" to those interpreting the data. Based on the recently published FDA draft guidance on LC studies, this talk will discuss statistical considerations on the design and analysis of these studies.

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Authors who are presenting talks have a * after their name.

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