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Activity Number:
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321
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Type:
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Contributed
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Date/Time:
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Wednesday, August 14, 2002 : 12:00 PM to 1:50 PM
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Sponsor:
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Biometrics Section*
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| Abstract - #301951 |
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Title:
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Group Sequential Test for Dissolution Quality Control
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Author(s):
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Meiyu Shen*+ 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, 15B45, Rockville, MD, 20857, USA
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Keywords:
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sequential test ; quality control ; dissolution
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Abstract:
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Regulatory decision is basically based on results of hypothesis testing. Although dissolution testing is an important element of drug quality control with clearly defined specification(s) that the drug tablet to dissolve for no less than pre-specified percentage Q at a given time point, the acceptance sampling plans of U.S. Pharmacopeia and European Pharmcopeia are not procedures proposed with clearly stated hypotheses for testing. On the other hand, the Japan Pharmacopeia plan is derived with the goal of testing whether the lot mean > Q. It can be shown with a simulation study that given a percentage of the lot be less that Q, all three Pharmacopeia procedures are shown to have unstable operating characteristics such that there is larger probability of acceptance when the lot mean is smaller. Tsong et al proposed for regulatory purpose to test for the hypothesis that Pr (X>Q) > 90%, requiring that at least 90% of the batch has dissolution greater Q for acceptance. They also proposed a maximum likelihood estimate procedure. We modified the procedure into a 3-stage group sequential testing plan with operating characteristics invariant to lot mean.
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