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 - #306970
Title: Some Reflections About Shelf Life
Author(s): Dennis Sandell*+
Companies: S5 Consulting / PQRI
Address: Järnåkravägen 3, Lund, 22225, Sweden
Keywords: shelf life
Abstract:

The shelf life of a pharmaceutical product is a key concept. The intention with this is to provide the user with guidance on how long the product can be used. ICH guidances describes shelf life as the time during which a pharmaceutical product consistently meets certain requirements that are needed to fulfill safety and efficacy claims, and also recommends a procedure how to determine the shelf life. When the PQRI SSL Working Group started its effort to study alternative shelf life estimation procedures it soon became apparent that published information concerning the formal "mathematical" definition of shelf life was unclear or even contradictory. A clarified language and alternative definitions were developed. Understanding the meaning and intention of a shelf life claim provides the framework for developing and comparing statistical methodologies consistent with the WG's discussions.


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