title: Estimating drug shelf-life with random batches.
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.
authors.affiliation: Biostatistics Department, Bristol-Myers Squibb Company, Plainsboro, New Jersey 08536.
authors.forename: S C
authors.initials: SC
authors.lastname: Chow
authors.forename: J
authors.initials: J
authors.lastname: Shao
mesh_terms: D004355:Drug Stability; D008433:Mathematics; D015233:Models, Statistical; D011897:Random Allocation; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration