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Table 1 Example of challenges encountered using predictive stability studies

From: Analytical approaches to ensure product quality -- AAPS Joint Face-to-Face Meeting of the Stability, the Pharmaceutical Impurities, and the CMC Statistics Focus Groups, April 6th, 2016 in Gaithersburg, MD

• Mistrust of models–lack of understanding–or too complex to model
• Lack of broad champion
• Lack of resources or different use of resources
• Lack of knowledge on approach
• Risk aversion
• Data quality is questioned if using low levels
• Product is too stable–difficult to develop predictive degradant model when change is small relative to noise
• If modeling is not successful for a product it may cast doubt on other products
• Challenges modeling dissolution