Stability and forced degradation studies
Understanding the stability of a drug product is crucial in all development phases
Stability testing and forced degradation studies (stress testing) play a central role in almost all development phases. During preformulation studies and formulation development, forced degradation is essential to understand the criticality of certain types of stress for the drug substance and to identify the most robust and stable formulation during development. The presence of a stressed and (partially) degraded sample is also the basis of any comprehensive analytical method development that allows for the quantification of undesired by-products. During developability and manufacturability assessment it is further crucial to simulate certain stress scenarios, including in-use stability. Finally, it is required to test the long-term stability of a drug product using the desired storage conditions.
We at Coriolis have over 10 years of experience with stability and forced degradation studies and our scientists are eager to apply their knowledge to support your drug development program.
Get in contact with our experts today and find out how a stability and forced degradation study can support your project.