Unlocking The Guidelines For Designing Drug Substance & Product Stability Studies

This audiocast discusses the guidelines for designing drug substance and product stability studies, which can be complex and challenging. The FDA provides general principles, but interpretation and uncertainty can arise regarding meeting FDA requirements. The International Conference on Harmonisation (ICH) provides guidelines for stability testing, including storage conditions, duration of testing, statistical analysis, and establishing shelf life. The audiocast explains the process of stability testing, which involves developing a protocol, conducting accelerated and long-term testing, monitoring stability, analyzing data, and reporting results. It emphasizes the importance of using validated methods and following regulatory guidance to ensure the safety and quality of drug products.