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Activity Number: 645
Type: Contributed
Date/Time: Thursday, August 7, 2014 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract #312494 View Presentation
Title: Alternative Procedures for Shelf Life Estimation Utilizing Mixed Models
Author(s): Michelle Quinlan*+ and Walt Stroup and Dave Christopher
Companies: Novartis and University of Nebraska-Lincoln and Merck
Keywords: shelf life ; mixed model ; ICH ; quantile regression
Abstract:

Shelf life is the length of time a product is expected to remain within the established acceptance criteria. The traditional metric for assessing shelf life is the regression line. The criterion for determining shelf life involves insuring that all future batches meet or exceed the established shelf life of the product with an acceptably high probability. Given this criterion which involves prediction, batch effects are most appropriately modeled as random. Two new procedures have been developed which employ a model where batch effects are considered random: (1) utilizing batch specific Best Linear Unbiased Prediction (BLUP) and focusing on the batch with the shortest shelf life; and (2) utilizing BLUP combined with quantile regression techniques. Both procedures seek to estimate a suitably small quantile of the distribution of batch shelf lives while accounting for the inherent variability among batch shelf lives. The methodology and implementation of these procedures for shelf life estimation are discussed and the results are compared to previously developed shelf life estimation procedures.


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