๐”– Bobbio Scriptorium
โœฆ   LIBER   โœฆ

PREDICTION BOUNDS FOR RANDOM SHELF-LIVES

โœ Scribed by JUN SHAO; LING CHEN

Publisher
John Wiley and Sons
Year
1997
Tongue
English
Weight
307 KB
Volume
16
Category
Article
ISSN
0277-6715

No coin nor oath required. For personal study only.

โœฆ Synopsis

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.

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