ABSTRACT
As stability information becomes established it serves as a comparison for future development. If production process, formulation, or packaging changes during or after development are contemplated, the effect of the change on stability must be evaluated. This is especially important for compounds or formulations that are relatively labile. Recent guidelines or draft guidelines describe stability studies needed for postapproval changes, where the definitive stability has already been established (4). In most cases, a study under accelerated conditions for 3 months and a concurrent room temperature study are needed to support changes with the potential to impact stability behavior. Before committing the resources and time necessary to produce material and conduct such studies, it is valuable to have an indication that the studies will be successful, i.e., that the change will not have an adverse effect on stability. A rapid indication of stability impact is also helpful in guiding additional development or optimization work.
