Accelerated Stability Assessment with Luminata

This technical report discusses the Accelerated Stability Assessment Program (ASAP) and the use of Luminata in simplifying stability assessments for drug products. It outlines the challenges faced by researchers in performing accelerated stability analysis, particularly the inefficiencies associated with manual data transcription and the lack of integration with analytical software. The report details the mathematical foundations of accelerated stability calculations, including the modified Arrhenius equation used to predict degradation rates based on temperature and humidity. It explains how Luminata's workflow facilitates the processing of analytical data, allowing scientists to efficiently determine degradant levels and calculate necessary parameters for stability prediction. Additionally, the report describes Luminata's modeling and visualization tools that enable users to forecast degradation profiles and generate comprehensive reports. By streamlining the stability research process, Luminata aims to enhance productivity in pharmaceutical development and improve the quality of medicines.