An overview of stability studies

Before any drug products are marketed, it is required by the government regulatory agencies that stability studies to be conducted. The objective of the stability studies is not only to characterize the degradation curve but also to estimate the shelf-life of the drug products. The estimated shelf-life gives a certain assurance that the drug products retains its identity, strength, quality and purity during the time period. In this paper, we give an overview of the stability studies, which includes the historical background, comparisons of guidelines among various countries, recent developments, as well as future research topics.

Duke Scholars

Author Shein-Chung Chow Biostatistics & Bioinformatics, Division of Biostatistics