JSM 2004 - Toronto

Abstract #301692

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Activity Number: 221
Type: Contributed
Date/Time: Tuesday, August 10, 2004 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301692
Title: Pooling Stability Data for Estimating Drug Product Shelf Life
Author(s): Harry Yang and Ryan Yamagata*+ and Iksung Cho
Companies: MedImmune, Inc. and MedImmune Vaccines and MedImmune Vaccines
Address: 297 N. Bernardo Ave., Mountain View, CA, 94043,
Keywords: stability study ; degradation rte ; poolability testing ; shelf life
Abstract:

The regulatory guidelines mandate that the shelf life or expiration dating of a drug product be estimated based on a stability study that involves several lots of the product. Regression analysis is often used for this purpose. The shelf life is determined to be the time when the lower confidence limit of predicted mean value intercepts the lower specification limit, either based on pooled lots or data from the lot that results in the shortest shelf life. We discuss several issues regarding the pooling test. Graphical and analytical methods are proposed for the determination of shelf life, under various scenarios regarding whether or not data are poolable to estimate a common slope and/or common intercept. A closed-form solution to shelf life is provided. Applications of the two methods to various real-life problems are also presented.

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Revised March 2004