Mastering Stability Studies: The Blueprint for Drug Substance & Product Success

The podcast provides an overview of drug substance and product stability testing. They describe the importance of stability testing for ensuring product quality and safety. The texts highlight the complexity of FDA stability guidelines, which are intended to provide general principles for conducting stability testing. The sources then outline the specific guidelines for stability testing established by the International Conference on Harmonisation (ICH) and provide a step-by-step process for conducting stability testing. Finally, the texts emphasize the importance of following regulatory guidance and using validated methods to ensure the accuracy and reliability of stability testing data.

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