Combined statistical analyses for long-term stability data with multiple storage conditions: a simulation study.

Shelf-life estimation usually requires that at least three registration batches are tested for stability at multiple storage conditions. The shelf-life estimates are often obtained by linear regression analysis per storage condition, an approach implicitly suggested by ICH guideline Q1E. A linear regression analysis combining all data from multiple storage conditions was recently proposed in the literature when variances are homogeneous across storage conditions.

Closed-form confidence intervals on measures of precision for an interlaboratory study.

Within the pharmaceutical industry it is common practice to transfer analytical methods from one laboratory to other laboratories. An experiment or interlaboratory study is performed to estimate the repeatability, the intermediate precision, and the reproducibility of the analytical method. These measures of precision are quantified by appropriate sums of variance components from an analysis of variance model describing the structure of the data.