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Activity Number: 67
Type: Contributed
Date/Time: Sunday, August 6, 2006 : 4:00 PM to 5:50 PM
Sponsor: Section on Quality and Productivity
Abstract - #305439
Title: Stochastic Models for Predicting Product Failure Rate of Parenterals Due to Particulate Matter
Author(s): Chi-Hse Teng*+
Companies: Pfizer Inc.
Address: Science Center Drive, San Diego, CA, 92121,
Keywords: particulate matter ; CMC ; quality control ; prediction ; parenterals
Abstract:

Since the 60s, many articles have discussed the particulate issue in parenteral product, such as safety concerns, sources of particulates, and analytical chemistry methods for detecting particulates. However, the method for predicting the chance of the final product meeting the specifications limit has not been well established, which is useful for the developer and reviewer. The failure rate can be established empirically or predicted by models. In many cases, due to limited resources, it is not possible to estimate the failure rate empirically. We will discuss several stochastic models for different situations, including Poisson renewal processes model, overdispersion model for limits with single-size category and multiple-size category, and log normal model.

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Revised April, 2006