JSM 2003 Online Program

Abstract #300307

This is the preliminary program for the 2003 Joint Statistical Meetings in San Francisco, California. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 2-5, 2003); 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:	135
Type:	Luncheons
Date/Time:	Monday, August 4, 2003 : 12:30 PM to 1:50 PM
Sponsor:	Biopharmaceutical Section
Abstract - #300307
Title:	Vaccine Lot Consistency Issues
Author(s):	Peter A. Lachenbruch*+
Companies:	Food and Drug Administration
Address:	CDER, Biostatistics Branch HFM-215, Rockville, MD, 20852-1428,
Keywords:	vaccines ; lot consistency ; equivalence ; overlap distributions
Abstract:	It is important for vaccine lots to be manufactured consistently--they should produce an antibody level that varies only slightly from lot to lot. This is essentially an equivalence problem. Methods that have been proposed include examining the maximum t-test, finding the largest confidence interval, analysis of variance, and the noncentral range distribution. Recently, methods based on density estimation have been proposed. These methods will be discussed among participants, and other issues can be raised.

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