The pharmaceutical development process is a complex, multi-phase journey that transforms a drug idea into a marketable product. This process typically includes
several key phases: drug discovery, preclinical development, clinical trials (Phases I, II, and III), and regulatory approval, followed by post-marketing surveillance. Integral to each phase of development is the collection of stability data on the active Drug Substance and the final Drug Product.
Stability testing demonstrates that the product maintains its quality throughout its shelf life and helps identify potential risks associated with the product’s degradation. By identifying degradation pathways and their kinetics early in development, pharmaceutical companies can develop strategies to mitigate these risks, reducing the risk of adverse events and recalls.
