Forced Degradation Studies and LC-MS Multi-Attribute Monitoring (MAM)

CASSS AT Europe 2020 -- Forced degradation studies involve subjecting a putative drug substance or drug product to elevated chemical and environmental stress. This allows product degradation pathways and potential impact on efficacy or safety to be understood. It is also used to challenge the sensitivity and specificity of analytical methods. Carrying them out early on in the assay development process limits risk. Forced degradation studies are a regulatory requirement, but in most cases there are no defined procedures in the regulatory guidance. Covance is therefore developing a standardised forced degradation strategy.