Unlocking Drug Stability: A Statistical Insight Across Accelerated, Intermediate, and Real-Time Conditions

Background/Objectives: The stability of pharmaceutical compounds is a critical quality attribute; it is an essential step in the drug development process. Significant focus is required to understand the variation of quality pharmaceutical compounds under prevailing environmental storage conditions. Simultaneously, many issues arise in understanding updated regulations, knowledge of data sciences, and appreciation of common practices, presenting a challenge for defining a retest period and in predicting a prolongation of the shelf life of drug products. The purpose of this paper is to conduct a statistical study to assess stability and to forecast a prolongation of drugs shelf-life. Methods: A case study is suggested to identify the most appropriate statistical test for assessing stability. The results of physical and chemical tests are considered to detect changes and variability during different conditions (accelerate, intermediate and real). Results: In the stability study, minimal variability in the content of the substance of interest was obtained using the predictive interval approach over a period of 31 months, and an interval of ±1,2%. Conclusion: The example of the statistical study is given to provide different perspectives on statistical approaches for market approval.