JSM 2011 Online Program

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Abstract Details

Activity Number: 626
Type: Contributed
Date/Time: Thursday, August 4, 2011 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #301015
Title: Development of a Content Uniformity Test Suitable for Medium and Large Sample Sizes
Author(s): Xiaoyu Dong*+ and Yi Tsong
Companies: University of Maryland at Baltimore County and U.S. Food and Drug Administration/CDER
Address: Department of Math and Statistics,University of Ma, Baltimore, MD, 21250,
Keywords: content uniformity ; two one-sided tests
Abstract:

For a therapeutic product, most of the dose contents should within (85,115)% of label claim to assure the homogeneity of the product. We can evaluate the content uniformity through sampling acceptance plan which is required by FDA. Due to the limitation of laboratory measurement, current statistical strategies are based on 30 tablets. However, with the development of near infrared spectroscopy (NIRS), hypothesis test for large sample sizes is becoming feasible. In this project, we compare the properties of three potential statistical strategies "PhRMA counting method", "Two one-sided tests(TOST)" and "Equal-tailed tolerance Interval" , and choose TOST as a suitable test for large sample size. By controlling the power, we develop a two-step procedure for the null hypothesis specification adjusted for various sample sizes in the TOST setting.


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