Stability analysis with discrete responses.

Shein-Chung Chow; Jun Shao

doi:10.1081/bip-120022766

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Stability analysis with discrete responses.

Shein-Chung Chow·Jun Shao

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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.

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Confidence Intervals Drug Stability Drug Storage Models, Statistical Multivariate Analysis Time Factors Journal Article

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Shein-Chung Chow, Jun Shao. 2003. Stability analysis with discrete responses.. https://doi.org/10.1081/bip-120022766

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