Prediction bounds for random shelf-lives.
Every drug product requires indication of a shelf-life on the immediate container label. The labelled shelf-life is usually determined by a stability analysis with several batches of the drug product. Because of the existence of batch-to-batch variation, the true shelf-lives of different batches differ and can be treated as random variables. To obtain a single labelled shelf-life applicable to all future batches of the drug product, we propose to use a prediction bound of the random shelf-life of a future batch. Under some assumptions, the proposed labelled shelf-life (prediction bound) is lower than the true random shelf-life with a probability approximately equal to a pre-assigned level. For illustration, we provide an example concerning a new drug application stability analysis conducted in a pharmaceutical company. We also discuss an application of our technique to the problem of clean-up of contaminated soils.
Shao
J
J
Department of Statistics, University of Wisconsin, Madison 53706, USA.
Chen
L
L
D003666:Decontamination; D004341:Drug Evaluation; D004348:Drug Labeling; D004349:Drug Packaging; D006256:Hazardous Waste; D006801:Humans; D015233:Models, Statistical; D013997:Time Factors
D006256:Hazardous Waste