This podcast summarizes the key concepts, regulations, and practical considerations for drug stability studies, as outlined in the provided excerpts. The core aim of these studies is to ensure the safety and efficacy of drug products throughout their intended shelf-life by establishing suitable storage conditions and monitoring product quality over time. Stability studies are a regulatory requirement and are conducted at various stages of the drug lifecycle, from early development through ongoing commercial production. They involve real-time and accelerated testing under controlled conditions, evaluating a range of product characteristics including identity, purity, and potency.