An Introduction to the Accelerated Stability Assessment Program

Stability studies are a time consuming and resource intensive task in the development of new drugs. Therefore products are tested under accelerated conditions to increase the rate of chemical and/or physical degradation. Based on the Arrhenius equation the chemical degradation increases with the temperature and therefore it should be possible to project the degradation rate at low temperature from the data generated under accelerated or stressed conditions. However, the predictive power of those experiments is not always sufficient. On the one hand, long-term studies or real-time studies are still needed and experience shows often different results between accelerated and long-term conditions. On the other hand, it is not possible to increase the temperature unlimited to get meaningful results at high temperature. Baking a cake at 160°C for 30 minutes is not the same as baking a cake at 240°C for 1 minute. Key Words: Predictive, Arrhenius, ASAP

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