This member only benchmarking survey looks at: FDS conditions for formal comparability package suitable to be submitted to a regulator and how it is evaluated? How much do companies do for comparability assessments? Are there changes to strategy depending on stage of...
The use of forced degradation oxidation studies was explored in several meetings using live polls which encouraged interaction and discussion. The challenge for oxidation forced degradation studies is to understand which degradation pathways are relevant for...
The team shared approaches on the use of forced degradation studies for DP (lyo to liquid formulation swap). Discussion covered using real-time data to compare, use of accelerated stability and the timing of the swap.
Forced degradation studies (FDS) are a crucial part of the drug lifecycle process because companies need to fully understand their molecule, including how it reacts to different stress conditions. However, there is a lack of clear regulatory guidance on how, when and...
