Abstract Details
Activity Number:
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37
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Type:
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Contributed
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Date/Time:
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Sunday, August 3, 2014 : 2:00 PM to 3:50 PM
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Sponsor:
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Quality and Productivity Section
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Abstract #311572
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View Presentation
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Title:
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Statistical Properties of Large Sample Tests for Dose Content Uniformity
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Author(s):
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Meiyu Shen*+ and Yi Tsong and Xiaoyu Dong
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Companies:
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FDA and FDA and FDA
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Keywords:
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dose content uniformity ;
large sample sizes ;
tolerance interval ;
OC curve ;
acceptance probability
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Abstract:
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Test for uniformity of dosage units using large sample sizes in European Pharmacopoeia 7.7 consists of 2 tests. EU Option 1 is a parametric two-sided tolerance interval based method modified with an indifference zone and counting units outside of(0.75M,1.25M), here Xbar=sample mean and M=98.5% if Xbar< 98.5%, M=101.5% if Xbar>101.5%,and M=xbar o.w. EU Option 2 is a nonparametric counting method with an indifference zone. We extended the parametric two one-sided tolerance intervals based method proposed by Tsong for dose content uniformity test with 30 tablets and by Shen & Tsong for large sample sizes with the restriction that all operating characteristic (OC)curves of two one-sided tolerance intervals for any given sample size intersect with OC curve of USP harmonized method for 30 tablets at 90% acceptance probability assuming data normally distributed with 100%LC mean. We compared the acceptance probabilities of EU Options 1 and 2 and our proposed method by simulation and found that both EU methods produce larger acceptance probabilities for off target mean. For a given variability, the acceptance probability of EU option 2 at mean of 102%LC is larger than that at mean of 100%LC.
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Authors who are presenting talks have a * after their name.
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