The main objective of a stability study is to provide supportive data on the drug substance/product quality. The product is tested at different conditions (based on regulatory requirements) which ultimately will determine the product shelf-life and storage conditions. The data is gained by placing the product in controlled storage conditions followed by analytical, physical, and microbial testing at pre-defined time points.
Stability program for a Clinical Trial Material (CTM) batch is usually composed of two types of stability studies: long term stability (also called real-time stability) and accelerated stability. Long term stability studies provide evidence on the product's quality under the manufacturer's recommended storage conditions. Accelerated stability studies are conducted in order to predict the stability of the drug under real-time conditions. This prediction is based on the Arrhenius equation which states that chemical degradation increases with the temperature.
The first full-length stability program is usually conducted in parallel or adjacent to the clinical trial. This means that the product going into clinical testing is lacking the stability data to support its shelf life. In such cases, approval for starting the clinical trial will be given based on the extrapolation of the accelerated stability data.
Tip from our scientists
Many regulators, including the FDA and the EMA, requires that stability storage conditions will be according to the International Conference on Harmonisation (ICH) guidelines. These guidelines, commonly referred to as ICH-conditions, represent the most common combinations of temperature and relative humidity (RH) in four climatic zones. Therefore, stability conditions should be chosen based on product characteristics and the climatic zone of the intended market.