All pharmaceutical products are required by law to display the shelf-life on the packaging, which indicates the period during which the consumer can expect the product to be safe and effective. Standard methods for determining the label shelf- life from stability data are limited to linear models. Where a number of batches are used to determine a label shelf-life, the current regulatory method (unintentionally) penalizes good statistical design. In this work it is shown that the current approaches may not provide the consumer with the desired level of confidence that the product is...