The purpose of forced degradation studies is to facilitate development of analytical methods that are stability-indicating for the analysis of pharmaceutical products. Recent resolutions by ANVISA (Brazilian Health Authority) and other health authorities have placed greater scrutiny on forced degradation studies and the analytical methods that are used to evaluate degradation products in manufactured pharmaceutical formulations. Using case studies, best practices will be discussed to outline how forced degradation studies should be conducted, focusing on challenges when limited degradation or significant secondary degradation products are observed. Additionally, strategies for communicating results of forced degradation studies and justification of the analytical method to health authorities will be provided.

Forced degradation case studies in pharmaceutical product development and communication strategies to global health authorities

255th National Meeting (2018)

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