Stability analysis with discrete responses.

Published

Journal Article

We consider the estimation of shelf life of a drug product when the stability data are discrete. When there is no batch-to-batch variation, the proposed shelf life estimator is an approximate 95% lower confidence bound of the true shelf life. In the presence of batch-to-batch variation, the proposed shelf life estimator is an approximate 95% lower prediction bound of the shelf life of future batches. As a result, the proposed shelf life is applicable to all future batches of the same drug product. Testing for batch-to-batch variation based on discrete responses is also discussed.

Full Text

Duke Authors

Cited Authors

  • Chow, S-C; Shao, J

Published Date

  • August 2003

Published In

Volume / Issue

  • 13 / 3

Start / End Page

  • 451 - 462

PubMed ID

  • 12921393

Pubmed Central ID

  • 12921393

International Standard Serial Number (ISSN)

  • 1054-3406

Digital Object Identifier (DOI)

  • 10.1081/BIP-120022766

Language

  • eng

Conference Location

  • England