STATISTICAL CONSIDERATIONS ON DOSE CONTENT UNIFORMITY (DCU) TEST WITH SMALL, MEDIUM AND LARGE SAMPLE SIZES
View Presentation *Meiyu Shen, FDA Yi Tsong, FDA Keywords: dose content uniformity, large sample size Dose uniformity is one of most critical requirements of pharmaceutical products. Current two-tier procedure is a modification of the USPXXVI sampling plan of dose content uniformity. Due to using a zero tolerance criterion, it has a near-zero probability acceptance at the second tier. Increased risk to manufacturers of unnecessarily rejecting good product may arise from current testing paradigms-zero tolerance criteria, utilizing increased sampling, such as medium and large samples in dose uniformity testing. We propose a two-tier sequential tolerance interval approach, equivalent to a two-tier two one-sided testing procedure, controlling the probability to a product delivering below a pre-specified dose and the probability of a product delivering over a pre-specified dose. When generalizing the test to medium or large sample, the specification reflects the requirement for quality.
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Key Dates
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April 30 - May 22, 2013
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June 4, 2013
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August 9 - August 23, 2013
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August 23, 2013
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August 26, 2013
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September 9, 2013
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September 16 - September 18, 2013
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