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