title: Stability analysis with discrete responses.
abstract: 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.
authors.affiliation: Milliennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA.
authors.forename: Shein-Chung
authors.initials: SC
authors.lastname: Chow
authors.forename: Jun
authors.initials: J
authors.lastname: Shao
mesh_terms: D016001:Confidence Intervals; D004355:Drug Stability; D004356:Drug Storage / Q000592:standards / Q000706:statistics & numerical data; D015233:Models, Statistical; D015999:Multivariate Analysis; D013997:Time Factors