Automated stability assessment process for early development

Forced degradation studies can provide information on the relative stability of a drug compound in various solutions, suspensions, and in the solid state, as well as the pathways for degradation. Carrying out forced degradation studies as part of the compound selection process is desirable since this information can be used to choose appropriate salts and polymorphs, to optimize the stability of the drug in formulations, and to aid in analytical method development. Automation of these studies becomes almost mandatory as large numbers of potential new drug entities move from the Discovery Phase to the Development Phase. An Automated Stability Assessment Process (ASAP) will be discussed.