This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 17
Type: Topic Contributed
Date/Time: Sunday, August 1, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307026
Title: Current Practices in Shelf Life Estimation
Author(s): James Schwenke*+
Companies: Boehringer Ingelheim Pharmaceuticals, Inc.
Address: 900 Ridgebury Road, Ridgefield, CT, 06877-0368,
Keywords: shelf life ; estimation ; pooling
Abstract:

Current practices as suggested by the ICH guidelines for the estimation of shelf life are based on the results of a stability study involving a minimum of three batches of the pharmaceutical product. The suggested statistical methodology considers batch as a fixed effect, allowing for the pooling of the data from the batches if there are no significant batch effects, using a=0.25. Typically, 95% confidence intervals are constructed for the individual or pooled batch mean response which is used to determine the allowable shelf life claim. Using a real life data set, the current shelf life estimation methodology will be demonstrated, highlighting some of the controversial aspects of the methodology that inspired the PQRI Stability Shelf Life Working Group.


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