Stability analysis with discrete responses.
Journal Article (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
International Standard Serial Number (ISSN)
- 1054-3406
Digital Object Identifier (DOI)
- 10.1081/BIP-120022766
Language
- eng
Conference Location
- England