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Activity Number:
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233
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304167 |
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Title:
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Nonparametric Tolerance Interval Approach for Specifications
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Author(s):
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Meiyu Shen*+ and Yi Tsong
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Companies:
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FDA and FDA
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Address:
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10903 New Hampshire Ave, Sliver Spring, MD, 20993,
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Keywords:
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delivery dose ; tolerance interval
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Abstract:
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Specifications are the critical requirements of pharmaceutical products. Dose content uniformity is such an example. The two-tier procedure is a modification of the USP sampling plan of dose content uniformity which employed a zero tolerance criterion. The USP procedure has a near-zero probability acceptance at the second tier. Hence, it increased the manufacturers' risk of unnecessarily rejecting good products due to the current zero tolerance criteria, when a larger sampling size, such as medium and large samples in dose uniformity testing is used. In this presentation, we propose a two-tier sequential nonparametric tolerance interval approach that is equivalent to a two-tier two one-sided testing procedure. We will discuss several ways to compute the nonparametric tolerance interval for the single population and two-population cases.
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- Authors who are presenting talks have a * after their name.
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