Physical Sciences and Mathematics Commons^™

Best Linear Unbiased Prediction: An Illustration Based On, But Not Limited To, Shelf Life Estimation, Maryna Ptukhina, Walter Stroup

Conference on Applied Statistics in Agriculture

Shelf life estimation procedures, following ICH guidelines, use multiple batch regression with fixed batch effects. This guidance specifically mandates estimates based on at least 3 batches. Technically, the fixed-batch model limits inference to the batches actually observed, whereas ICH requires resulting estimates to apply to all future batches stored under similar conditions. This creates a conflict between the model used and the inference space the model is intended to address. Quinlan, et al. (2013) and Schwenke (2010) studied the small sample behavior of this procedure. Both studies revealed large sampling variation associated with the ICH procedure, producing a substantial proportion …