RBPS tools, such as the ASAP and other models, are used routinely within pharmaceutical development to quickly assess stability characteristics, especially to understand mechanisms of degradation. These modeling tools provide stability insights within weeks that could take months or years to understand using long-term stability conditions only. Despite their usefulness, the knowledge gained through these tools is not as broadly used to support regulatory filing strategies. This study was done to communicate how the industry has used RBPS data to support regulatory submissions and discuss the regulatory feedback that was received.
Analysis of the collective recent regulatory experience suggests an apparent decrease in regulatory acceptance of the use of RBPS to set initial shelf-life. Companies with experience using these tools feel this is at odds with RBPS being a powerful and science-based tool for gaining a more rapid and thorough understanding of the stability characteristics of a drug substance and drug product. The depth of stability knowledge gained through an RBPS study typically well exceeds the information learned after the first 3-month time point of a long-term study where, for most well-designed products, changes are insignificant.