Accelerated stability studies definition
Accelerated stability studies means studies designed to determine the rate of change of vaccine properties over time as a consequence of the exposure to temperatures higher than those recommended for storage. These studies may provide useful support data for establishing the shelf-life or release specifications but should not be used to forecast real time real condition stability of a vaccine. They could also provide preliminary information on the vaccine stability at early developmental stages and assist in assessing stability profile of a vaccine after manufacturing changes.
Accelerated stability studies means studies designed to determine the rate of change of vaccine properties over time as a consequence of the exposure to