SOS-2015 Case Studies: Stress Testing Revealing Degradation Pathways:

Stress Testing Revealing Degradation Pathways:


Despite a thorough stability assessment, unexpected degradation processes can occur throughout every phase of drug development or even after market launch.

Since drug decomposition may have a myriad of manifold root causes, a well designed forced degradation strategy can help to reveal potential stability issues long before requiring exceptional financial and personnel expenditures to be resolved.

The presented case studies illustrate how forced degradation and subsequent investigations helped to identify, understand, and tackle degradation issues in a systematic way.