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