Presentation
Streamlining Data Management for Theoretical and Actual Degradants with Accelerated Stability Assessment
Joe DiMartino, Solution Area Manager, Luminata; ACD/Labs
Sarah Srokosz, and Joe DiMartino
Forced degradation studies play a vital role in pharmaceutical development, helping researchers understand how drug substances and drug products break down under stress. These studies generate large amounts of data, from chemical structures to analytical results, that have traditionally been managed in time-consuming, error-prone processes using spreadsheets.
Luminata® is a decision support software that brings all the key data together—theoretical degradant data, analytical results, and process details—in one place. By letting scientists easily visualize degradation profiles and pinpoint how stress conditions affect drug stability, Luminata simplifies decision-making and ensures clear, reliable results.
This presentation will dive into the common challenges faced in forced degradation studies, such as fragmented data, where theoretical degradant data is stored separately from analytical data in the chromatography data system (CDS). Additionally, we will discuss how predictive stability data can be incorporated to enhance accelerated stability assessments. With tools such as Luminata to facilitate the integration of this data, researchers can readily gain deeper insights into degradation pathways and better understand forced degradation studies. We will expand on this to explore how better data management tools can make pharmaceutical stability studies faster and more effective.
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