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Activity Number:
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389
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Type:
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Contributed
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Date/Time:
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Thursday, August 15, 2002 : 8:30 AM to 10:20 AM
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Sponsor:
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Biometrics Section*
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| Abstract - #301894 |
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Title:
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Significance Levels for Stability Pooling Test: A Simulation Study
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Author(s):
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Wen-Jen Chen*+ and Yi Tsong
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Affiliation(s):
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Food and Drug Administration and Food and Drug Administration
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Address:
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5600 Fishers Lane, 9B07, Rockville, Maryland, 20857, USA
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Keywords:
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Multiple factor and matrixing stability design ; Stability pooling test ; Expiration date ; False positive rate ; Linear fixed effect model
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Abstract:
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Shelf life of a drug product is defined as the length of time under specific conditions of storage that the product will remain within specifications established to ensure its identity, strength, quality and purity. The objective of an NDA stability study is to collect and evaluate the evidence in support of the sponsor proposed shelf life. The proposed shelf life is supported when each batch of the drug products in the study has shelf life no shorter than the proposed shelf life. In practice, batches are pooled to have a common estimate of slope or regression line when there is no significant difference in slope or regression line. Such practice is often applied in pooling across levels of a design factor such as package or strength in a stability study designed with multiple factors. Through simulation study, it is shown that with the regularly used sample sized, a significance level of 0.23 is needed for the simple case of three batches stability analysis for slope or intercept pooling test in order to control type I rate approximately at 0.18 level for shelf life decision when data variation is small to moderate.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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