Estimating drug shelf-life with random batches.

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Chow, SC; Shao, J

Published Date

  • September 1, 1991

Published In

Volume / Issue

  • 47 / 3

Start / End Page

  • 1071 - 1079

PubMed ID

  • 1742431

International Standard Serial Number (ISSN)

  • 0006-341X


  • eng

Conference Location

  • United States