Estimating a Single Shelf‐Life for Multiple Batches

Pharmaceutical companies and manufacturers of food products are legally required to label the product's shelf‐life on the packaging. For pharmaceutical products the requirements for how to determine the shelf‐life are highly regulated. However, the regulatory documents do not specifically define the shelf‐life. Instead, the definition is implied through the estimation procedure. In this paper, the focus is on the situation where multiple batches are used to determine a label shelf‐life that is applicable to all future batches. Consequently, the short‐comings of existing estimation approaches are discussed. These are then addressed by proposing a new definition of shelf‐life and label shelf‐life, where greater emphasis is placed on within and between batch variability. Furthermore, an estimation approach is developed and the properties of this approach are illustrated using a simulation study. Finally, the approach is applied to real data.