The study of tolerance intervals for linear mixed models under unbalanced data has been mainly focused on one-way random-effects models. In this article, we present a method to compute both one- and two-sided ( β , γ ) -tolerance intervals that is applicable to a more general class of unbalanced linear mixed models. The proposed method is based on the concept of generalized pivotal quantities and thus relies on the derivation of pivotal quantities that are shown to be independent within this particular class of models. The method employs Monte Carlo sampling methods to obtain realizations of the quantities needed to compute the tolerance intervals of interest. Extensive simulation studies confirm that coverage probabilities of the computed tolerance intervals are consistently close to their nominal levels. Furthermore, to showcase the application of our method in real-world scenarios, we provide illustrative examples of case studies that examine models falling within the specified class. Lastly, motivated by the prospective application of our method in drug development, we implement the proposed procedures to estimate shelf life of a drug product through tolerance intervals and unbalanced stability data.
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