JSM 2005 Online Program

Abstract #303879

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Activity Number:	67
Type:	Contributed
Date/Time:	Sunday, August 7, 2005 : 4:00 PM to 5:50 PM
Sponsor:	Biopharmaceutical Section
Abstract - #303879
Title:	A Tolerance Interval-based, Two-stage Sequential Quality Assurance Test on Content Uniformity of Drug
Author(s):	Meiyu Shen*+ and Yi Tsong
Companies:	U.S. Food and Drug Administration and U.S. Food and Drug Administration
Address:	12720 Twinbrook Parkway, Rockville, MD, 20850, United States
Keywords:	dose uniformity of drug ; quality control
Abstract:	The USP content uniformity sampling acceptance plan consists of a two-stage sampling plan with criteria on sample mean and number of out-of-range tablets, which is the standard for compendium. It is, however, often used mistakenly for lot quality assurance. We propose a parametric tolerance interval procedure to test a two-sided specification equivalent to quality test of two one-sided hypotheses. Testing against a lower specification is to assure the drug product is not underdosed in terms of efficacy. On the other hand, testing against an upper specification is to assure the drug product is not overdosed in terms of safety. The operating curves of the proposed procedure are compared with that of the USP test to illustrate the difference in acceptance rate against the mean and variance of the lot.

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