JSM 2005 Online Program

Abstract #303377

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:	330
Type:	Contributed
Date/Time:	Tuesday, August 9, 2005 : 2:00 PM to 3:50 PM
Sponsor:	Biopharmaceutical Section
Abstract - #303377
Title:	Application of Monte Carlo Simulation Methods in Quality-control Areas
Author(s):	Ryan Yamagata*+ and Harry Yang and Andrew Chen and Iksung Cho
Companies:	MedImmune Vaccines, Inc. and MedImmune, Inc. and MedImmune, Inc. and MedImmune, Inc.
Address:	297 N Bernardo Ave, Mountain View, CA, 94043, United States
Keywords:	Simulation ; Quality Control (QC) ; Assay ; Stochastic Process Control ; Variation
Abstract:	Monte Carlo simulation methods often are used to solve statistical problems (both point estimation and hypothesis testing) when theoretical solutions are too hard to derive or a limited amount of data is available. We present three case studies to demonstrate how to use Monte Carlo simulations to evaluate performances of QC assays, streamline the QC testing scheme, and establish stochastic process control (SPC) criteria for positive assay controls used for final product lot release testing. We show the Monte Carlo method can be successfully implemented for understanding complicated statistical issues in the QC area of final product release and intermediate products without resorting to formidable statistical theory.

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