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  • Title: Estimating drug shelf-life with random batches.
    Author: Chow SC, Shao J.
    Journal: Biometrics; 1991 Sep; 47(3):1071-9. PubMed ID: 1742431.
    Abstract:
    The problem of assessing the shelf-lives of drug products in the market is considered. We focus on the situation where the drug characteristic of interest has a linear relationship over time and batch-to-batch variation is present. Two methods for assessing shelf-lives are proposed based on the weighted least squares method under a regression model with random coefficients. An application to some stability data from the pharmaceutical industry is presented.
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